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 @ 4:20 PM
Ignite Modification Date: 2025-12-25 @ 2:16 PM
NCT ID: NCT01706666
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01706666
Study Brief: Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. None None 1 1 1 1 View
Arm B Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. None None 0 1 1 1 View
Arm C Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28. None None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View