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NCT00652626 · ADVERSE EVENTS

Adverse events

Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function · Source last updated 2019-11-19

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
Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Azacitidine 25 mg/m^2

Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.

0 / 54 / 5Not reported / Not reported
Azacitidine 50 mg/m^2

Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.

0 / 53 / 5Not reported / Not reported
Azacitidine 75 mg/m^2

Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.

4 / 65 / 6Not reported / Not reported
Azacitidine 100 mg/m^2

Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.

1 / 55 / 5Not reported / Not reported
Severe RI: Azacitidine 75 mg/m^2

Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.

1 / 66 / 6Not reported / Not reported
Extension Phase: Normal RF

Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.

8 / 149 / 14Not reported / Not reported
Extension Phase: Severe RI

Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.

3 / 44 / 4Not reported / Not reported

Group identifiers: EG000: Azacitidine 25 mg/m^2 · EG001: Azacitidine 50 mg/m^2 · EG002: Azacitidine 75 mg/m^2 · EG003: Azacitidine 100 mg/m^2 · EG004: Severe RI: Azacitidine 75 mg/m^2 · EG005: Extension Phase: Normal RF · EG006: Extension Phase: Severe RI

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 (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Anemia
  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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Pancytopenia
  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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Small intestinal obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Vomiting
  6. 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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Hyponatremia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Confusional state
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Renal failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Renal vein thrombosis

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
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Lymphadenopathy
  4. 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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    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
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Pancytopenia
  6. 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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Thrombocytopenia
  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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Dyspepsia
Complete source fields
event Groups
  1. description
    Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Azacitidine 25 mg/m^2
  2. description
    Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Azacitidine 50 mg/m^2
  3. description
    Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Azacitidine 75 mg/m^2
  4. description
    Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Azacitidine 100 mg/m^2
  5. description
    Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
    id
    EG004
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Severe RI: Azacitidine 75 mg/m^2
  6. description
    Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
    id
    EG005
    other Num Affected
    9
    other Num At Risk
    14
    serious Num Affected
    8
    serious Num At Risk
    14
    title
    Extension Phase: Normal RF
  7. description
    Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Extension Phase: Severe RI
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
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Lymphadenopathy
  4. 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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    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
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Pancytopenia
  6. 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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Thrombocytopenia
  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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Dyspepsia
serious 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
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Anemia
  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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Pancytopenia
  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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Small intestinal obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Vomiting
  6. 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
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Hyponatremia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Confusional state
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Renal failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Renal vein thrombosis
time Frame
Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).

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Preserved source evidence · Not medical advice