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NCT02046070 · ADVERSE EVENTS

Adverse events

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma · Source last updated 2019-07-17

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
First dose of study drug through 30 days after last dose of drug (Up to 45 months)
Other-event reporting threshold
5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.

17 / 3634 / 363 / 36
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.

20 / 3434 / 342 / 34
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.

30 / 7869 / 785 / 78

Group identifiers: EG000: Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) · EG001: Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) · EG002: Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)

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
    notes
    One treatment-emergent death occurred during treatment with Ixazomib 4.0 mg + CYC 400 mg/m\^2 + DEX 40 mg (NDMM) and is not related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      78
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      78
    term
    Bronchitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      78
    term
    Lower respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      78
    term
    Upper respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Sinusitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Localised infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Diverticulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Gastroenteritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Septic shock
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      78
    term
    Pseudomembranous colitis

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
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      78
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      78
    term
    Bronchitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      78
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      78
    term
    Respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      78
    term
    Herpes zoster
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      78
    term
    Influenza
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      78
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      78
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      78
    term
    Lower respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      78
    term
    Pharyngitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      78
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      78
    term
    Oral herpes
Complete source fields
description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    36
    description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    36
    serious Num Affected
    17
    serious Num At Risk
    36
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
  2. deaths Num Affected
    2
    deaths Num At Risk
    34
    description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
    id
    EG001
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    20
    serious Num At Risk
    34
    title
    Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
  3. deaths Num Affected
    5
    deaths Num At Risk
    78
    description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
    id
    EG002
    other Num Affected
    69
    other Num At Risk
    78
    serious Num Affected
    30
    serious Num At Risk
    78
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      78
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      78
    term
    Bronchitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      78
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      78
    term
    Respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      78
    term
    Herpes zoster
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      78
    term
    Influenza
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      78
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      78
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      78
    term
    Lower respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      78
    term
    Pharyngitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      78
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      78
    term
    Oral herpes
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with Ixazomib 4.0 mg + CYC 400 mg/m\^2 + DEX 40 mg (NDMM) and is not related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      78
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      78
    term
    Bronchitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      78
    term
    Lower respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      78
    term
    Upper respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Sinusitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Localised infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Diverticulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Gastroenteritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      78
    term
    Septic shock
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      78
    term
    Pseudomembranous colitis
time Frame
First dose of study drug through 30 days after last dose of drug (Up to 45 months)

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Preserved source evidence · Not medical advice