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: 2025-12-24 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT00158756
Description: None
Frequency Threshold: 5
Time Frame: Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Study: NCT00158756
Study Brief: Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tritanrix™-HepB+Placebo Group Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. None None 0 25 25 25 View
Zilbrix™+Rotarix™ Group Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. None None 7 81 74 81 View
Zilbrix™+Placebo Group Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. None None 0 23 22 23 View
Triple Antigen™+Engerix™-B Group Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively. None None 2 99 96 99 View
Tritanrix™-HepB+Rotarix™ Group Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. None None 1 80 74 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injection site abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Laryngotracheitis obstructive SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Overgrowth bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT General disorders MedDRA View