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 @ 12:22 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT01702961
Description: Only related adverse events were collected for this study.
Frequency Threshold: 0
Time Frame: Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant.
Study: NCT01702961
Study Brief: Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rituxan+BEAM: Autologous Stem Cell Transplant Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0 None None 1 75 2 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular/ General - Other SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Pain - Other SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Stomatitis/pharyngitis (oral/pharyngeal mucositis) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View