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NCT02728102 · ADVERSE EVENTS

Adverse events

Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401) · Source last updated 2024-05-07

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide, Vaccine, and GM-CSF

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.

2 / 683 / 683 / 68
Lenalidomide and GM-CSF

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.

3 / 373 / 370 / 37
Maintenance Lenalidomide

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.

1 / 353 / 351 / 35

Group identifiers: EG000: Lenalidomide, Vaccine, and GM-CSF · EG001: Lenalidomide and GM-CSF · EG002: Maintenance Lenalidomide

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    NEUTROPENIC FEVER
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    PROLONGED QTC
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    ELEVATE LIVER ENZYMES
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    SYNCOPE
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    ATRIAL FLUTTER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    CONGESTIVE HEART FAILURE
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    MELANOMA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    LIVER FUNCTION TESTS INCREASED

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    LENTIGO MALIGNA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    ATRIAL FIBRILLATION
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    ELEVATED ALT
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    INCREASED ALT > 3.0 X ULN
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    PROSTATE CANCER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    ELEVATED LFT
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    GRADE 2 DVT
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    THROMBOEMBOLIC EVENT
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    GRADE 2 TRANSAMINITIS
Complete source fields
event Groups
  1. 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
  2. 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
  3. 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
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    LENTIGO MALIGNA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    ATRIAL FIBRILLATION
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    ELEVATED ALT
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    INCREASED ALT > 3.0 X ULN
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    PROSTATE CANCER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    ELEVATED LFT
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    GRADE 2 DVT
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    THROMBOEMBOLIC EVENT
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    GRADE 2 TRANSAMINITIS
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    NEUTROPENIC FEVER
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    PROLONGED QTC
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    ELEVATE LIVER ENZYMES
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    SYNCOPE
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      37
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    ATRIAL FLUTTER
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    CONGESTIVE HEART FAILURE
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.0-23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    MELANOMA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      37
      num Events
      1
    3. 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