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 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:56 PM
NCT ID: NCT05890794
Description: None
Frequency Threshold: 0
Time Frame: Day 1 to Day 15
Study: NCT05890794
Study Brief: Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.8 mg/kg Ilofotase Alfa Single dose administered intravenously over 1 hour Ilofotase Alfa, 0.8 mg/kg: Biological: single 1-hour intravenous infusion of 0.8 mg/kg ilofotase alfa 0 None 0 6 1 6 View
3.2 mg/kg Ilofotase Alfa Single dose administered intravenously over 1 hour Ilofotase Alfa, 3.2 mg/kg: Biological: single 1-hour intravenous infusion of 3.2 mg/kg ilofotase alfa 0 None 0 6 3 6 View
Overall Single dose administered intravenously over 1 hour Ilofotase Alfa, 0.8 or 3.2 mg/kg: Biological: single 1-hour intravenous infusion of 0.8 or 3.2 mg/kg ilofotase alfa 0 None 0 12 4 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Restless arm syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View