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NCT00642954 · ADVERSE EVENTS

Adverse events

Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074) · Source last updated 2020-11-18

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 to ~66 months (through database cut-off date of 20-August-2013)
Other-event reporting threshold
5%

Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg

Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.

2 / 44 / 40 / 4
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg

Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.

1 / 44 / 41 / 4
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg

Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.

1 / 33 / 30 / 3
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg

Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.

2 / 33 / 30 / 3
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg

Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.

8 / 1717 / 173 / 17

Group identifiers: EG000: Level 1: Vorinostat 300 mg + Lenalidomide 10 mg · EG001: Level 2: Vorinostat 400 mg + Lenalidomide 10 mg · EG002: Level 3: Vorinostat 400 mg + Lenalidomide 15 mg · EG003: Level 4: Vorinostat 400 mg + Lenalidomide 20 mg · EG004: Level 5: Vorinostat 400 mg + Lenalidomide 25 mg

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
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Extrasystoles
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Acute hepatic failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Bronchitis viral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Diverticulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pyelonephritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Septic shock

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 15.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      17
      num Events
      28
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      17
      num Events
      10
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      17
      num Events
      9
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      11
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      17
      num Events
      37
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      17
      num Events
      70
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Extrasystoles
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Ear pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Tinnitus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Periorbital oedema
Complete source fields
description
Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
  2. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
  5. deaths Num Affected
    3
    deaths Num At Risk
    17
    description
    Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
    id
    EG004
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    8
    serious Num At Risk
    17
    title
    Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      17
      num Events
      28
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      17
      num Events
      10
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      17
      num Events
      9
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      11
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      17
      num Events
      37
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      17
      num Events
      70
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Extrasystoles
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Ear pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Tinnitus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Periorbital oedema
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Extrasystoles
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Acute hepatic failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Bronchitis viral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Diverticulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pyelonephritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Septic shock
time Frame
Up to ~66 months (through database cut-off date of 20-August-2013)

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Preserved source evidence · Not medical advice