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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT01605032
Description: None
Frequency Threshold: 5
Time Frame: Up to 2 years
Study: NCT01605032
Study Brief: Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT) CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4. TRANSPLANT: Patients undergo autologous PBSCT on day 0. Busulfan: Given IV Melphalan: Given IV Bortezomib: Given IV Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT 1 None 1 19 19 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death - 70 days after the autologous stem cell transplant SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Transaminitis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Dysphagia/Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea and/or vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever without neutropenia SYSTEMATIC_ASSESSMENT General disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Noninfectious pulmonary toxicity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Electrolyte abnormalities SYSTEMATIC_ASSESSMENT General disorders None View
Oral mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View