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 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:03 PM
NCT ID:
NCT02272803
Description:
All randomized participants
Frequency Threshold:
5
Time Frame:
All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months).
Study:
NCT02272803
Study Brief:
Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
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: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) | Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1 | 2 | None | 26 | 40 | 39 | 40 | View |
| Arm B: Lenalidomide + Dexamethasone | Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle | 6 | None | 27 | 42 | 42 | 42 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Agranulocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 24.0 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 24.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Eosinophilic myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | 24.0 | View |
| Cataract subcapsular | SYSTEMATIC_ASSESSMENT | Eye disorders | 24.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Ischaemic enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 24.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 24.0 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 24.0 | View |
| Disseminated varicella zoster virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Peri-implantitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pneumonia cryptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pneumonia influenzal | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Near drowning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Chondrocalcinosis pyrophosphate | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Gastrointestinal stromal tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Papillary thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Rectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 24.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 24.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 24.0 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 24.0 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Drug reaction with eosinophilia and systemic symptoms | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Cataract operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 24.0 | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 24.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 24.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 24.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 24.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | 24.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | 24.0 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | 24.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Chronic gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Periodontal disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 24.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 24.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Hepatitis B reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 24.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Tooth fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 24.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 24.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 24.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 24.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 24.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 24.0 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 24.0 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 24.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 24.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Purpura | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 24.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 24.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 24.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 24.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 24.0 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 24.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 24.0 | View |