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 @ 11:17 PM
Ignite Modification Date: 2025-12-25 @ 8:56 PM
NCT ID: NCT02472756
Description: None
Frequency Threshold: 5
Time Frame: Up to 30 months
Study: NCT02472756
Study Brief: A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular 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
Follicular Lymphoma Participants Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months. None None 8 41 3 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukemias acute myeloid NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hypogammaglobulinaemia NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Tracheitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hepatitis B NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View