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: 2025-12-26 @ 12:14 PM
Ignite Modification Date: 2025-12-26 @ 12:14 PM
NCT ID: NCT00299000
Description: None
Frequency Threshold: 5
Time Frame: All patients received weekly infusions of Nagalzyme for a minimum of 52 weeks. The range in time of exposure to Naglazyme for the duration of the study was 52.9 to 153.30 weeks.
Study: NCT00299000
Study Brief: A Phase 4 Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With MPS VI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Naglazyme, 1.0 mg/kg weekly infusions for minimum of 52 weeks None None 2 2 2 2 View
Naglazyme, 2.0 mg/kg weekly infusions for minimum of 52 weeks None None 2 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adenoidal hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Cast application SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (12.0) View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Poor venous access SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (12.0) View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.0) View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.0) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Upper respiratory tract infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View