Adverse Events Module

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 @ 1:17 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT00966693
Description: None
Frequency Threshold: 0
Time Frame: Baseline to study completion up to 9 years
Study: NCT00966693
Study Brief: Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory 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
RTD (Cohort 1, Phase 1) Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle 0 None 0 3 3 3 View
RTD (Cohort 2, Phase 1) Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle 0 None 0 3 3 3 View
RTD (Cohort 3, Phase 1) Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle 1 None 1 9 9 9 View
RTD (Cohort 2, Phase 2) Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle 0 None 7 49 49 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Death SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Altered Mental Status SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v3.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Dry Eye Syndrome SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Edema Limbs SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Endocrine (other) SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE v3.0 View
Esophogeal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Eye Muscle Weakness SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Flashing Vision SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Flu-like Symptoms SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Gait Abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Gastric Infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3.0 View
Gastrointestinal General SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Glucose intolerance SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE v3.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Hearing Loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTCAE v3.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v3.0 View
Anemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Epstaxis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Hemorrhoidal/hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Hemorrhage Urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v3.0 View
Hiccough SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3.0 View
INR Increase SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3.0 View
Irratibility SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3.0 View
Jejunal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Joint Disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Lymphatics (Other) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3.0 View
Localized Edema SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3.0 View
Memory Impairement SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Metabolic/Laboratory (Other) SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Mucosal Infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3.0 View
Mucositis Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Musculoskeletal (Other) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Muscle Weakness Lower Limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Musculoskelatal (Other) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Myalgia SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Mycardial Ichemia SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Neurology (Other) SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
ANC Decrease SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Ocular/Visual (Other) SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Osteoporsis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTCAE v3.0 View
Pain SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Pain (Other) SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Photosensitivity SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Thromboctopenia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Pulmonary (Other) SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Rash acneform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3.0 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3.0 View
Renal/Genitourinary (Other) SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v3.0 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3.0 View
Hypoalbumenia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypermagnesmia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypercholesteremia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Sinus Brdaycardia SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Sinus Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Taste Alteration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Tinitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTCAE v3.0 View
Speech Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3.0 View
Treatment related to Secondary Malignancy SYSTEMATIC_ASSESSMENT Surgical and medical procedures NCI CTCAE v3.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View
Tumor Lysis Syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v3.0 View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Urinary Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v3.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v3.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v3.0 View
Urostomy stenosis SYSTEMATIC_ASSESSMENT Surgical and medical procedures NCI CTCAE v3.0 View
Vaginal hemmorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCI CTCAE v3.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Vascular (other) SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v3.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Voice Alteration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Watering Eyes SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Weight Gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v3.0 View
Activated PTT SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Acidosis SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Adult Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3.0 View
ALT Increase SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Alkaline Phosphate increase SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Allergy SYSTEMATIC_ASSESSMENT Immune system disorders NCI CTCAE v3.0 View
Anal Hemmorhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v3.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3.0 View
AST Increase SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Atrial Injury SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Auditory Ear (Other) SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTCAE v3.0 View
Autoimmune Disorder (Other) SYSTEMATIC_ASSESSMENT Immune system disorders NCI CTCAE v3.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Hyperbilirubia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hypocarpnia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Blood Bone Marrow (other) SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Bone Development Abnormal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
BonePain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3.0 View
Bronchial Hemmorhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Brusing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Cardiac General (Other) SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Hypocaligulopathy SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Conjunctival disorder SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v3.0 View
Constitutional Symptoms SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE v3.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3.0 View
Creatinine increase SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v3.0 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders NCI CTCAE v3.0 View
Dehydration SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3.0 View
Depressed Conciousness Level SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3.0 View
Dermatological/Skin (other) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3.0 View
Diastolic Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3.0 View