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 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
NCT ID:
NCT00691704
Description:
Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.
Frequency Threshold:
0
Time Frame:
Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness.
Study:
NCT00691704
Study Brief:
Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| High-risk Multiple Myeloma | Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on | None | None | 4 | 18 | 18 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Supraventricular and nodal arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Congestive Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Ventricular Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cardiac Ischemia / infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Acute Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Muscular / skeletal hypoplasia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Thrombosis / thrombus / embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Otitis, external ear (non-infectious) | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE version 3.0 | View |
| thrombosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Bacteremia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Leukocytes (total WBC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Lymphocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Constitutional Symptoms - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Decreased Libido | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Fatigue (asthenia, lethargy, malaise) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Rigors / chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Sweating (diaphoresis) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Excoriation bilateral dorsal aspect of feet, related to scratching | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Hyperpigmentation - nailbeds | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Induration, CS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Peeling skin, intermittent, NCS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Redness-feet | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Right ankle erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Hair Loss / Alopecia (scalp or body) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Pruritus / itching | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Rash / desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Hot flashes / flushes | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE version 3.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Heartburn / dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Taste Alteration (dysgeusia) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Hemorrhage / Bleeding - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Infection - Other (Cellulitis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 3.0 | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 3.0 | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 3.0 | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Albumin, serum-low (hypoalbuminemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Alkaline phosphatase | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Calcium, serum-low (hypocalcemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Magnesium, serum-low (hypomagnesemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Phosphate, serum-low (hypophosphatemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Potassium, serum-high (hyperkalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Potassium, serum-low (hypokalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Sodium, serum-low (hyponatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Decreased Neutrophils | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Uric Acid, serum-high (hyperuricemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Arthritis (non-septic) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | View |
| Joint-function | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | View |
| Osteonecrosis (avascular necrosis) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | View |
| Ataxia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Parasthesias | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Mood Swings | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Cognitive disturbance | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Mood Alteration - Anxiety | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Mood Alteration - Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Neuropathy: motor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Neuropathy: sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Syncope (fainting) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Dry Eye Syndrome | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 3.0 | View |
| Ocular / Visual - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 3.0 | View |
| Vision - blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 3.0 | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | View |
| Pain - General | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Pain - Head / headache | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 3.0 | View |
| Pain - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE version 3.0 | View |
| Bronchospasm, wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Cyanosis of toes | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Pneumonitis / pulmonary infiltrates | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Pulmonary / Upper Respiratory - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Orthopnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 3.0 | View |
| Renal / Genitourinary - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 3.0 | View |
| Malodorous urine | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 3.0 | View |
| Urinary frequency / urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 3.0 | View |
| Urinary retention (including neurogenic bladder) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE version 3.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Early satiety, CS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Esophageal spasms | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Food Aversions, CS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Increased thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Oral lesion | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Bilateral facial swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Paresthesias- Intermittent | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Right Breast Pressure | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Sore throat intermittent | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Sternal Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Dermatology / Skin - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Cold sore - left upper lip | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Contact dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Neutrophils / granulocytes (ANC / AGC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Cardiac General - Other (Specify, __) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 3.0 | View |
| Cardiac Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 3.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 3.0 | View |
| Cardiac Left Ventricular Function | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 3.0 | View |