Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:18 AM
Ignite Modification Date: 2025-12-25 @ 10:21 PM
NCT ID: NCT00432458
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00432458
Study Brief: Zoledronate With or Without Thalidomide in Treating Patients With Early Stage 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
Arm I: Thal/ZLD Thalidomide (Thal) + Zolendronic acid (ZLD) None None 3 35 35 35 View
Arm II: ZLD Zoledronic acid (ZLD) None None 1 33 28 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Ureteral Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Ischemia/Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Otitis External SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Fever-No ANC SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Rigors SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
CPK (creatine phosphokinase) SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Prothrombin Time SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Ischemia-Cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Neuro-Cranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Vasovagal Episode SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Ureteral Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Rash/Desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Rash/dermatitis associated with high-dose chemotherapy or BMT studies. SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View