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 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:02 AM
NCT ID: NCT00322218
Description: Only study drug-related AEs was collected until the end of Stage 1 in case of a relapse.Patients who relapsed before study treatment were to be followed up in the same way as patients in observation arm,if a patient randomized to the observation arm received treatment for a relapse, no further AE reporting was required.
Frequency Threshold: 5
Time Frame: Followed up until last anti-lymphoma treatment or 42 months whichever is longer.
Study: NCT00322218
Study Brief: Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zevalin Zevalin Therapeutic Regimen: Day 1: 250 mg/m\^2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m\^2 Rituxan followed by 0.4 mCi/kg Zevalin. None None 2 34 5 34 View
Observation Patients in this arm were diagnosed with diffuse large B-cell lymphoma and were in complete remission after first-line CHOP-R therapy. Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse. None None 1 34 1 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infections and manifestations NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View