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NCT03112603 · ADVERSE EVENTS

Adverse events

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) · Source last updated 2025-08-12

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
from Baseline to LPLV (approximately 5 years)
Other-event reporting threshold
5%

Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ruxolitinib

Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).

86 / 165158 / 16537 / 165
Best Available Therapy

Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.

71 / 158132 / 15840 / 158
Ruxolitinib Cross-Over Period

Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.

27 / 7062 / 7010 / 70

Group identifiers: EG000: Ruxolitinib · EG001: Best Available Therapy · EG002: Ruxolitinib Cross-Over Period

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Atypical haemolytic uraemic syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Spleen disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Splenic haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Thrombotic microangiopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Acute myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Aortic valve incompetence

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      70
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      70
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      70
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      70
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      70
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      70
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      70
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      70
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Vomiting
Complete source fields
description
Treatment-emergent adverse events, defined as adverse events that started or worsened during the on-treatment period (either Randomized or Cross-over Period), have been reported for the Safety Set, which included participants who received at least one dose of drug. A total of 6 participants in the BAT arm discontinued before receiving the first dose.
event Groups
  1. deaths Num Affected
    37
    deaths Num At Risk
    165
    description
    Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
    id
    EG000
    other Num Affected
    158
    other Num At Risk
    165
    serious Num Affected
    86
    serious Num At Risk
    165
    title
    Ruxolitinib
  2. deaths Num Affected
    40
    deaths Num At Risk
    158
    description
    Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
    id
    EG001
    other Num Affected
    132
    other Num At Risk
    158
    serious Num Affected
    71
    serious Num At Risk
    158
    title
    Best Available Therapy
  3. deaths Num Affected
    10
    deaths Num At Risk
    70
    description
    Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
    id
    EG002
    other Num Affected
    62
    other Num At Risk
    70
    serious Num Affected
    27
    serious Num At Risk
    70
    title
    Ruxolitinib Cross-Over Period
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      70
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      70
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      70
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      70
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      70
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      70
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      70
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      70
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Atypical haemolytic uraemic syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Spleen disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Splenic haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Thrombotic microangiopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Acute myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Aortic valve incompetence
time Frame
from Baseline to LPLV (approximately 5 years)

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Preserved source evidence · Not medical advice