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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:01 AM
NCT ID: NCT03043105
Description: None
Frequency Threshold: 0
Time Frame: Safety data were collected until 30 days after the last dose of study drugs, except for secondary primary malignancies (which were assessed throughout the duration of follow-up, up to 4 years). Secondary primary malignancies were assessed throughout the duration of follow-up, up to 3 years.
Study: NCT03043105
Study Brief: TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TCP Treatment Group The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows. * Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year; * Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year; * Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year. 3 None 2 25 10 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pulmonary infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View