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NCT02907359 · ADVERSE EVENTS

Adverse events

Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs · Source last updated 2024-08-27

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 first dose through end of study (up to approximately 46.6 months)
Other-event reporting threshold
5%

All-cause mortality:The Efficacy Analysis Set included all participants randomly assigned to study treatment. Serious and other adverse events:The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen. As pre-specified in the protocol, participants were grouped, and data was collected according to treatment received (Guadecitabine/Treatment Choice)for adverse events.

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

Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).

216 / 270266 / 270237 / 277
Treatment Choice

Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.

65 / 122107 / 122122 / 140

Group identifiers: EG000: Guadecitabine · EG001: Treatment Choice

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 21.0
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      122
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      122
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      122
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      122
    term
    Febrile Bone Marrow Aplasia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      122
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Leukostasis Syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Lymphadenitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Lymphadenopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Splenic Infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Thrombocytopenic Purpura

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 21.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      122
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      122
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      122
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      122
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      122
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      122
    term
    Abdominal Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      122
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      122
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      122
    term
    Haemorrhoids
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      122
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      122
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      122
    term
    Vomiting
Complete source fields
description
All-cause mortality:The Efficacy Analysis Set included all participants randomly assigned to study treatment. Serious and other adverse events:The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen. As pre-specified in the protocol, participants were grouped, and data was collected according to treatment received (Guadecitabine/Treatment Choice)for adverse events.
event Groups
  1. deaths Num Affected
    237
    deaths Num At Risk
    277
    description
    Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
    id
    EG000
    other Num Affected
    266
    other Num At Risk
    270
    serious Num Affected
    216
    serious Num At Risk
    270
    title
    Guadecitabine
  2. deaths Num Affected
    122
    deaths Num At Risk
    140
    description
    Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
    id
    EG001
    other Num Affected
    107
    other Num At Risk
    122
    serious Num Affected
    65
    serious Num At Risk
    122
    title
    Treatment Choice
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      122
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      122
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      122
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      122
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      122
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      122
    term
    Abdominal Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      122
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      122
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      122
    term
    Haemorrhoids
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      122
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      122
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      122
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      122
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      122
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      122
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      122
    term
    Febrile Bone Marrow Aplasia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      122
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Leukostasis Syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Lymphadenitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Lymphadenopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Splenic Infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      270
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      122
    term
    Thrombocytopenic Purpura
time Frame
From first dose through end of study (up to approximately 46.6 months)

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