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 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT04654351
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Data for injection site reactions were collected separately from general reports of AEs. As pre-defined in the protocol, an injection site reaction not meeting SAE criteria was not required to be reported additionally as an AE.
Frequency Threshold: 5
Time Frame: Up to approximately 6 months
Study: NCT04654351
Study Brief: A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TAK-667 10-30 mg TAK-667 five-weight-band dosing of up to maximum of 30 mg injection, SC, once on Day 1, and if necessary (there was insufficient relief or worsening of symptoms), up to two additional doses with a time interval of at least 6 hours between doses within 48 hours of initial injection per attack for up to 3 HAE attacks till the end of study (approximately 6 months). The dose of TAK-667 depended upon the participant's body weight (10 mg for 12 kg to 25 kg, 15 mg for 26 kg to 40 kg, 20 mg for 41 kg to 50kg, 25 mg for 51 kg to 65 kg, 30 mg for \>65 kg). 0 None 0 2 0 2 View
Serious Events(If Any):
Other Events(If Any):