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: 2025-12-25 @ 12:46 AM
Ignite Modification Date: 2025-12-25 @ 10:59 PM
NCT ID: NCT01242267
Description: The limited number of patients limited our ability to analyze groups separately. As a result, all subjects in the Phase I portion were combined to produce a meaningful analysis.
Frequency Threshold: 0
Time Frame: None
Study: NCT01242267
Study Brief: Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase I - Thalidomide Dose Level 600 mg Phase I - Thalidomide Dose Level 600 mg 0 None 1 3 3 3 View
Phase I - Thalidomide Dose Level 800 mg Phase I - Thalidomide Dose Level 800 mg 0 None 0 3 3 3 View
Phase I - Thalidomide Dose Level 1000 mg Phase I - Thalidomide Dose Level 1000 mg 0 None 0 3 3 3 View
Phase 2 Phase 2 Thalidomide Dose Level 1000 mg 0 None 3 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Engraftment Syndrome with GI Invovlement SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rheumatoid Arthritis Flare SYSTEMATIC_ASSESSMENT Immune system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tumor Lysis Syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mild Left Atrial Dilatation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Deep Venous Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acid Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain/Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Failure to Thrive SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renail Impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fluid Overload SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Hesitancy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostatism SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tumor Lysis Syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile Neutropenia (culture-negative) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint Effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Weakness Low Extremity/Generalized SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low Extremity Pain/Cramping SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low Extremity Edema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Soft Tissue Mass of the Hand SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Breast Discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View