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 @ 5:06 PM
Ignite Modification Date: 2025-12-24 @ 5:06 PM
NCT ID: NCT00793650
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00793650
Study Brief: Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bortezomib Before HD Melphalan All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2 None None 4 19 19 19 View
Bortezomib After HD melphalanAll patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2 None None 2 20 18 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Expired None General disorders None View
Acute pulmonary embolus None General disorders None View
Hemorrhage/Bleeding-Hemorrhage None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Muscositis None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Febrile Neutropenia None Blood and lymphatic system disorders None View
Sepsis None Infections and infestations None View
Liver Toxicities None Hepatobiliary disorders None View
Clostridium diificile None Gastrointestinal disorders None View
Renal toxicities None Renal and urinary disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Cognitive disturbances None Nervous system disorders None View
Seizures None Nervous system disorders None View
DVT/PE None Vascular disorders None View
Esophagitis None Gastrointestinal disorders None View
Hypernatremia None General disorders None View
Headaches None General disorders None View
Bone Pain None Musculoskeletal and connective tissue disorders None View
Pulmonary toxicities None Respiratory, thoracic and mediastinal disorders None View
Incontinenece None Renal and urinary disorders None View
Gastrointestinal bleed None Gastrointestinal disorders None View
Neutopenic colitis None Gastrointestinal disorders None View
Blisters on Feet None Skin and subcutaneous tissue disorders None View
Urinary retension None Renal and urinary disorders None View
Hypotension None Cardiac disorders None View
A.fib None Cardiac disorders None View
sinus bradycardia None Cardiac disorders None View