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NCT00507442 · ADVERSE EVENTS

Adverse events

Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients · Source last updated 2013-07-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
Other-event reporting threshold
5%

From first dose of any study drug to end of treatment period

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
V-DR

VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.

17 / 4241 / 42Not reported / Not reported
VDCR

VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.

26 / 6665 / 66Not reported / Not reported
V-DC

VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.

7 / 3333 / 33Not reported / Not reported
VDC-mod

Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

7 / 1717 / 17Not reported / Not reported

Group identifiers: EG000: V-DR · EG001: VDCR · EG002: V-DC · EG003: VDC-mod

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
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Pneumonia NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Lobar pneumonia NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Septic shock
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Herpes simplex
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Herpes zoster
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Urinary tract infection NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Respiratory syncytial virus infection NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Arthritis infective NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Colitis pseudomembranous
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Stye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Influenza

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
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      17
    term
    Peripheral neuropathy NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Peripheral sensory neuropathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      17
    term
    Dizziness (excl vertigo)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Dysgeusia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    term
    Paraesthesia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Hypoaesthesia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Tremor
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      17
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Gastro-oesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      17
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      17
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Flatulence
Complete source fields
description
From first dose of any study drug to end of treatment period
event Groups
  1. description
    VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    42
    serious Num Affected
    17
    serious Num At Risk
    42
    title
    V-DR
  2. description
    VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
    id
    EG001
    other Num Affected
    65
    other Num At Risk
    66
    serious Num Affected
    26
    serious Num At Risk
    66
    title
    VDCR
  3. description
    VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
    id
    EG002
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    7
    serious Num At Risk
    33
    title
    V-DC
  4. description
    Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
    id
    EG003
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    7
    serious Num At Risk
    17
    title
    VDC-mod
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      17
    term
    Peripheral neuropathy NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Peripheral sensory neuropathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      17
    term
    Dizziness (excl vertigo)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Dysgeusia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    term
    Paraesthesia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Hypoaesthesia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Tremor
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      17
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Gastro-oesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      17
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      17
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Flatulence
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Pneumonia NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Lobar pneumonia NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Septic shock
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Herpes simplex
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Herpes zoster
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Urinary tract infection NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Respiratory syncytial virus infection NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Arthritis infective NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Colitis pseudomembranous
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    term
    Stye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      66
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      33
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    term
    Influenza
time Frame
From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days

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Preserved source evidence · Not medical advice