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NCT00075829 · ADVERSE EVENTS

Adverse events

Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102) · Source last updated 2021-11-01

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
3-years post-first transplant
Other-event reporting threshold
.2%

Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events were required to be reported through the adverse event system per protocol.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Auto-Auto Standard Risk

Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients

15 / 4361 / 436Not reported / Not reported
Auto-Allo Standard Risk

Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients

10 / 1891 / 189Not reported / Not reported
Auto-Auto High Risk

Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients

2 / 480 / 48Not reported / Not reported
Auto-Allo High Risk

Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients

5 / 370 / 37Not reported / Not reported

Group identifiers: EG000: Auto-Auto Standard Risk · EG001: Auto-Allo Standard Risk · EG002: Auto-Auto High Risk · EG003: Auto-Allo High Risk

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 v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      37
    term
    Thrombocytopenic purpura
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Myocardial infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Deafness
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Diplopia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Diverticulum
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Accidental death
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      37
    term
    Mucosal inflammation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Non-cardiac chest pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Cholecystitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Anaphylactic reaction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Engraftment syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      37
    term
    Graft versus host disease

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Angiosarcoma
Complete source fields
description
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events were required to be reported through the adverse event system per protocol.
event Groups
  1. description
    Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    436
    serious Num Affected
    15
    serious Num At Risk
    436
    title
    Auto-Auto Standard Risk
  2. description
    Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    189
    serious Num Affected
    10
    serious Num At Risk
    189
    title
    Auto-Allo Standard Risk
  3. description
    Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    48
    serious Num Affected
    2
    serious Num At Risk
    48
    title
    Auto-Auto High Risk
  4. description
    Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    37
    serious Num Affected
    5
    serious Num At Risk
    37
    title
    Auto-Allo High Risk
frequency Threshold
.2
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Angiosarcoma
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      37
    term
    Thrombocytopenic purpura
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Myocardial infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Deafness
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Diplopia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Diverticulum
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Accidental death
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      37
    term
    Mucosal inflammation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Non-cardiac chest pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Cholecystitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Anaphylactic reaction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      37
    term
    Engraftment syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      436
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      189
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      37
    term
    Graft versus host disease
time Frame
3-years post-first transplant

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