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 @ 11:57 PM
Ignite Modification Date: 2025-12-25 @ 9:53 PM
NCT ID: NCT00508651
Description: Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
Frequency Threshold: 1
Time Frame: Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Study: NCT00508651
Study Brief: A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age
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 Placebo Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. None None 0 8 8 8 View
Cohort 1 MEDI-560 MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. None None 1 20 19 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 12.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 12.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 12.0 View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 12.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 12.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 12.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 12.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 12.0 View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 12.0 View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 12.0 View
Candida nappy rash SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 12.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 12.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 12.0 View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 12.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 12.0 View
Listless SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 12.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 12.0 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 12.0 View
Rhonchi SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 12.0 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 12.0 View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 12.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 12.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 12.0 View