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NCT01957644 · ADVERSE EVENTS

Adverse events

Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML · Source last updated 2019-02-08

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 randomisation until data cut-off (16Dec2016); up to 159 weeks
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1

Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)

6 / 66 / 6Not reported / Not reported
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1

Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)

2 / 65 / 6Not reported / Not reported
Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1

Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort

0 / 11 / 1Not reported / Not reported
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2

Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)

0 / 22 / 2Not reported / Not reported
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2

Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)

1 / 11 / 1Not reported / Not reported

Group identifiers: EG000: Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 · EG001: Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 · EG002: Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 · EG003: Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 · EG004: Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2

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 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Chest pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    General physical health deterioration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Systemic inflammatory response syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cholecystitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Anal abscess
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Skin infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Urosepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    C-reactive protein increased

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 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cyclic neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiovascular disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Coronary artery stenosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Mitral valve incompetence
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Thyroid mass
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Eye haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Scleral haemorrhage
Complete source fields
event Groups
  1. description
    Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    6
    serious Num At Risk
    6
    title
    Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
  2. description
    Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
  3. description
    Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
  4. description
    Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
  5. description
    Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cyclic neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiovascular disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Coronary artery stenosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Mitral valve incompetence
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Thyroid mass
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Eye haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Scleral haemorrhage
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Chest pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    General physical health deterioration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Systemic inflammatory response syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cholecystitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Anal abscess
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Skin infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Urosepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    C-reactive protein increased
time Frame
From randomisation until data cut-off (16Dec2016); up to 159 weeks

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Preserved source evidence · Not medical advice