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NCT00773838 · ADVERSE EVENTS

Adverse events

Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095) · Source last updated 2021-04-01

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
Up tp approximately 22 months for non-serious adverse events (AEs). Up to approximately 40 months for serious AEs and all-cause mortality.
Other-event reporting threshold
5%

All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all enrolled participants who received at least 1 dose of study treatment. Only serious AEs were collected for participants treated on extension.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Vorinostat + Bortezomib

Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.

92 / 142140 / 14285 / 143

Group identifiers: EG000: Vorinostat + Bortezomib

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      142
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      142
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Hyperviscosity syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Lymphadenitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      142
      num Events
      6
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      2
    term
    Angina unstable
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Myocardial ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Tachycardia

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      142
      num Events
      231
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      142
      num Events
      74
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      142
      num Events
      135
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      142
      num Events
      582
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      142
      num Events
      13
    term
    Vision blurred
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      142
      num Events
      9
    term
    Abdominal discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      142
      num Events
      25
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      142
      num Events
      18
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      142
      num Events
      47
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      142
      num Events
      189
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      142
      num Events
      10
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      142
      num Events
      16
    term
    Dyspepsia
Complete source fields
description
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all enrolled participants who received at least 1 dose of study treatment. Only serious AEs were collected for participants treated on extension.
event Groups
  1. deaths Num Affected
    85
    deaths Num At Risk
    143
    description
    Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
    id
    EG000
    other Num Affected
    140
    other Num At Risk
    142
    serious Num Affected
    92
    serious Num At Risk
    142
    title
    Vorinostat + Bortezomib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      142
      num Events
      231
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      142
      num Events
      74
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      142
      num Events
      135
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      142
      num Events
      582
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      142
      num Events
      13
    term
    Vision blurred
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      142
      num Events
      9
    term
    Abdominal discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      142
      num Events
      25
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      142
      num Events
      18
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      142
      num Events
      47
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      142
      num Events
      189
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      142
      num Events
      10
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      142
      num Events
      16
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      142
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      142
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Hyperviscosity syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Lymphadenitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      142
      num Events
      6
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      2
    term
    Angina unstable
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Myocardial ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    Tachycardia
time Frame
Up tp approximately 22 months for non-serious adverse events (AEs). Up to approximately 40 months for serious AEs and all-cause mortality.

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