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 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
NCT ID:
NCT01109004
Description:
None
Frequency Threshold:
1
Time Frame:
None
Study:
NCT01109004
Study Brief:
Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tandem Auto Transplant | Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms. | None | None | 42 | 247 | 0 | 247 | View |
| RVD Consolidation | Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms. | None | None | 45 | 254 | 0 | 254 | View |
| Lenalidomide Maintenance | Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms. | None | None | 53 | 257 | 0 | 257 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bradycardia | None | Cardiac disorders | None | View |
| Arthroscopy | None | Investigations | None | View |
| Glioblastoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Autonomic neuropathy | None | Nervous system disorders | None | View |
| Cerebral ischaemia | None | Nervous system disorders | None | View |
| Respiratory distress | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Haemolytic anaemia | None | Blood and lymphatic system disorders | None | View |
| Splenic infarction | None | Blood and lymphatic system disorders | None | View |
| Acute myocardial infarction | None | Cardiac disorders | None | View |
| Atrial fibrillation | None | Cardiac disorders | None | View |
| Cardiac failure congestive | None | Cardiac disorders | None | View |
| Cardiac tamponade | None | Cardiac disorders | None | View |
| Cardiac valve disease | None | Cardiac disorders | None | View |
| Cardio-respiratory arrest | None | Cardiac disorders | None | View |
| Left ventricular failure | None | Cardiac disorders | None | View |
| Myocardial infarction | None | Cardiac disorders | None | View |
| Sinus bradycardia | None | Cardiac disorders | None | View |
| Supraventricular tachycardia | None | Cardiac disorders | None | View |
| Torsade de pointes | None | Cardiac disorders | None | View |
| Cataract | None | Eye disorders | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Abdominal pain upper | None | Gastrointestinal disorders | None | View |
| Colitis ischaemic | None | Gastrointestinal disorders | None | View |
| Gastric haemorrhage | None | Gastrointestinal disorders | None | View |
| Gastrointestinal haemorrhage | None | Gastrointestinal disorders | None | View |
| Haemorrhoids | None | Gastrointestinal disorders | None | View |
| Impaired gastric emptying | None | Gastrointestinal disorders | None | View |
| Inguinal hernia, obstructive | None | Gastrointestinal disorders | None | View |
| Pancreatitis | None | Gastrointestinal disorders | None | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | None | View |
| Bile duct stone | None | Hepatobiliary disorders | None | View |
| Cholecystitis | None | Hepatobiliary disorders | None | View |
| Cholecystitis acute | None | Hepatobiliary disorders | None | View |
| Appendicitis | None | Infections and infestations | None | View |
| Gastroenteritis viral | None | Infections and infestations | None | View |
| Cervical vertebral fracture | None | Injury, poisoning and procedural complications | None | View |
| Fall | None | Injury, poisoning and procedural complications | None | View |
| Fracture | None | Injury, poisoning and procedural complications | None | View |
| Hip fracture | None | Injury, poisoning and procedural complications | None | View |
| Subdural haematoma | None | Injury, poisoning and procedural complications | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Hepatic enzyme increased | None | Investigations | None | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Joint range of motion decreased | None | Musculoskeletal and connective tissue disorders | None | View |
| Muscular weakness | None | Musculoskeletal and connective tissue disorders | None | View |
| Rhabdomyolysis | None | Musculoskeletal and connective tissue disorders | None | View |
| Acute leukaemia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Acute myeloid leukaemia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Acute promyelocytic leukaemia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Adenocarcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Basal cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Bladder cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Colon cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Colon cancer metastatic | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Endometrial cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Gastric cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Hodgkin's disease | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Intraductal proliferative breast lesion | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Malignant melanoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Metastasis | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Myelodysplastic syndrome | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Papillary thyroid cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Prostate cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Transitional cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cerebral venous thrombosis | None | Nervous system disorders | None | View |
| Cerebrovascular accident | None | Nervous system disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Haemorrhage intracranial | None | Nervous system disorders | None | View |
| Neuropathy peripheral | None | Nervous system disorders | None | View |
| Posterior reversible encephalopathy syndrome | None | Nervous system disorders | None | View |
| Spinal cord compression | None | Nervous system disorders | None | View |
| Syncope | None | Nervous system disorders | None | View |
| Mania | None | Psychiatric disorders | None | View |
| Mental status changes | None | Psychiatric disorders | None | View |
| Acute kidney injury | None | Renal and urinary disorders | None | View |
| Renal failure | None | Renal and urinary disorders | None | View |
| Acute respiratory distress syndrome | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Acute respiratory failure | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Interstitial lung disease | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary hypertension | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Cataract operation | None | Surgical and medical procedures | None | View |
| Cholecystectomy | None | Surgical and medical procedures | None | View |
| Umbilical hernia repair | None | Surgical and medical procedures | None | View |
| Deep vein thrombosis | None | Vascular disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Superior vena cava syndrome | None | Vascular disorders | None | View |
Other Events(If Any):