NCT02728102 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- 2 years
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Lenalidomide, Vaccine, and GM-CSF | 2 / 68 | 3 / 68 | 3 / 68 |
| Lenalidomide and GM-CSF | 3 / 37 | 3 / 37 | 0 / 37 |
| Maintenance Lenalidomide | 1 / 35 | 3 / 35 | 1 / 35 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- NEUTROPENIC FEVER
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 20.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- PROLONGED QTC
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 21.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- ELEVATE LIVER ENZYMES
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- SYNCOPE
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 35
- num Events
- 1
- term
- ATRIAL FLUTTER
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- CONGESTIVE HEART FAILURE
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- MELANOMA
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- LIVER FUNCTION TESTS INCREASED
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- LENTIGO MALIGNA
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- ATRIAL FIBRILLATION
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- ELEVATED ALT
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 20.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 35
- num Events
- 1
- term
- INCREASED ALT > 3.0 X ULN
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 35
- num Events
- 1
- term
- PROSTATE CANCER
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 22.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 35
- num Events
- 1
- term
- ELEVATED LFT
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA 22.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- GRADE 2 DVT
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- THROMBOEMBOLIC EVENT
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 22.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- GRADE 2 TRANSAMINITIS
Complete source fields
- event Groups
- deaths Num Affected
- 3
- deaths Num At Risk
- 68
- description
- Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation. Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy. Myeloma vaccine: The target dose is 3 x 10\^6 fusion cells per vaccine. A minimum of 3 x 10\^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance. GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle.
- id
- EG000
- other Num Affected
- 3
- other Num At Risk
- 68
- serious Num Affected
- 2
- serious Num At Risk
- 68
- title
- Lenalidomide, Vaccine, and GM-CSF
- deaths Num Affected
- 0
- deaths Num At Risk
- 37
- description
- Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery). Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation. Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy. GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.
- id
- EG001
- other Num Affected
- 3
- other Num At Risk
- 37
- serious Num Affected
- 3
- serious Num At Risk
- 37
- title
- Lenalidomide and GM-CSF
- deaths Num Affected
- 1
- deaths Num At Risk
- 35
- description
- Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide. Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery). Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation. Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices. Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
- id
- EG002
- other Num Affected
- 3
- other Num At Risk
- 35
- serious Num Affected
- 1
- serious Num At Risk
- 35
- title
- Maintenance Lenalidomide
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- LENTIGO MALIGNA
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- ATRIAL FIBRILLATION
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- ELEVATED ALT
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 20.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 35
- num Events
- 1
- term
- INCREASED ALT > 3.0 X ULN
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 35
- num Events
- 1
- term
- PROSTATE CANCER
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 22.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 35
- num Events
- 1
- term
- ELEVATED LFT
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA 22.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- GRADE 2 DVT
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- THROMBOEMBOLIC EVENT
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 22.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- GRADE 2 TRANSAMINITIS
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- NEUTROPENIC FEVER
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 20.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- PROLONGED QTC
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 21.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- ELEVATE LIVER ENZYMES
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 68
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- SYNCOPE
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 37
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 35
- num Events
- 1
- term
- ATRIAL FLUTTER
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- CONGESTIVE HEART FAILURE
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- MedDRA 20.0-23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- MELANOMA
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 68
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 37
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 35
- num Events
- 0
- term
- LIVER FUNCTION TESTS INCREASED
- time Frame
- 2 years
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Preserved source evidence · Not medical advice
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