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 @ 3:56 AM
Ignite Modification Date: 2025-12-26 @ 2:47 AM
NCT ID: NCT03192202
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT03192202
Study Brief: AFM13 in Relapsed/Refractory Cutaneous Lymphomas
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 1.5 mg/kg of AFM13 once weekly for weeks 1-8. AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed. 0 None 1 3 0 3 View
Cohort 4 200 mg ( Flat dose) of AFM13 once weekly for weeks 1-8. AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed. 0 None 0 6 0 6 View
Cohort 2 7.0 mg/kg of AFM13 once weekly for weeks 1-8. AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed. 1 None 1 3 3 3 View
Cohort 3 7.0 mg/kg CIVI of AFM13 once weekly for weeks 1-8. AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed. 0 None 0 3 0 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
G3/4 Infection and skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
G1 IRR SYSTEMATIC_ASSESSMENT General disorders None View
Death, G3 infection, IRR SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infusion related reaction (IRR) SYSTEMATIC_ASSESSMENT General disorders None View