NCT01995708 · 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
- 1 year
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm 1 Vaccine | 3 / 13 | 13 / 13 | 12 / 13 |
| Arm 2 Control | 2 / 15 | 15 / 15 | 8 / 15 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Dehydration
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Resp, thoracic & mediastinal disorder Other, spec
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Catheter related infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Hypertension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Lung infection
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 15
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Hyperglycemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Hypocalcemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Hyponatremia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 15
- term
- Hypophosphatemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 15
- term
- Lymphocyte count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 15
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 15
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 15
- term
- White blood cell decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Lung infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Rash maculo-papular
Complete source fields
- event Groups
- deaths Num Affected
- 12
- deaths Num At Risk
- 13
- description
- This is a prospective, two-arm phase I randomized trial. Patients will be accrued only from and treated at MSKCCand The Rockefeller University/Center for Clinical \& Translational Science . The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Twenty patients will accrue to the study and ten will receive vaccines at 9x10\^6 LCs per dose (i.e., combination of 3x10\^6 CT7 mRNA-electroporated LCs + 3x10\^6 MAGE-A3 mRNA-electroporated LCs + 3x10\^6 WT1 mRNA-electroporated LCs) and another ten who will not receive any LC vaccines but will otherwise undergo identical cytoreduction, ASCT, and standard supportive care. At approximately 3 months after ASCT and as deemed clinically appropriate, patients will start lenalidomide maintenance therapy, which is now standard to delay disease progression. CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs): Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant. Patients on the vaccine arm of the study will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after ASCT followed by two boosters at days +30 and +90. Vaccines will be dosed at 9x10\^6 LCs per vaccine x 3.
- id
- EG000
- other Num Affected
- 13
- other Num At Risk
- 13
- serious Num Affected
- 3
- serious Num At Risk
- 13
- title
- Arm 1 Vaccine
- deaths Num Affected
- 8
- deaths Num At Risk
- 15
- description
- Patients receive standard of care treatment after autologous stem cell transplant Standard of care: No vaccines
- id
- EG001
- other Num Affected
- 15
- other Num At Risk
- 15
- serious Num Affected
- 2
- serious Num At Risk
- 15
- title
- Arm 2 Control
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 15
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Hyperglycemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Hypocalcemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Hyponatremia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 15
- term
- Hypophosphatemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 15
- term
- Lymphocyte count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 15
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 15
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 15
- term
- White blood cell decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Lung infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Rash maculo-papular
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Dehydration
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- term
- Resp, thoracic & mediastinal disorder Other, spec
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Catheter related infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Hypertension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- term
- Lung infection
- time Frame
- 1 year
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Preserved source evidence · Not medical advice
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