Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00507416 · ADVERSE EVENTS

Adverse events

Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone · Source last updated 2014-05-01

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
Adverse events were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 49 weeks.
Other-event reporting threshold
0%

Per protocol, all grades of peripheral neuropathy and skeletal events, Grade 3/4 AEs, and all SAEs were recorded. There may be grade 1 or 2 events that were not required to be collected.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bortezomib and Dexamethasone

Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

88 / 16557 / 165Not reported / Not reported
Bortezomib, Thalidomide, and Dexamethasone

Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

92 / 15868 / 158Not reported / Not reported
Bortezomib, Melphalan and Prednisone

Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

83 / 16368 / 163Not reported / Not reported

Group identifiers: EG000: Bortezomib and Dexamethasone · EG001: Bortezomib, Thalidomide, and Dexamethasone · EG002: Bortezomib, Melphalan and Prednisone

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 (15.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      163
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Lobar pneumonia
  3. 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
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Bronchitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      163
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      163
    term
    Bacteraemia
  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
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Septic shock
  7. 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
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Bacterial sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Device related sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Urosepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      163
    term
    Urinary tract infection
  11. 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
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Pyelonephritis acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      163
    term
    Gastroenteritis

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
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      163
    term
    Weight decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      163
    term
    Platelet count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      163
    term
    Blood sodium decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      163
    term
    Blood uric acid increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      163
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      163
    term
    Blood alkaline phosphatase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Blood urea increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Protein total increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Weight increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Troponin T increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Blood calcium increased
Complete source fields
description
Per protocol, all grades of peripheral neuropathy and skeletal events, Grade 3/4 AEs, and all SAEs were recorded. There may be grade 1 or 2 events that were not required to be collected.
event Groups
  1. description
    Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    EG000
    other Num Affected
    57
    other Num At Risk
    165
    serious Num Affected
    88
    serious Num At Risk
    165
    title
    Bortezomib and Dexamethasone
  2. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    EG001
    other Num Affected
    68
    other Num At Risk
    158
    serious Num Affected
    92
    serious Num At Risk
    158
    title
    Bortezomib, Thalidomide, and Dexamethasone
  3. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    EG002
    other Num Affected
    68
    other Num At Risk
    163
    serious Num Affected
    83
    serious Num At Risk
    163
    title
    Bortezomib, Melphalan and Prednisone
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      163
    term
    Weight decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      163
    term
    Platelet count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      163
    term
    Blood sodium decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      163
    term
    Blood uric acid increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      163
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      163
    term
    Blood alkaline phosphatase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Blood urea increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Protein total increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Weight increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Troponin T increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Blood calcium increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      163
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      163
    term
    Lobar pneumonia
  3. 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
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Bronchitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      163
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      163
    term
    Bacteraemia
  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
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Septic shock
  7. 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
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Bacterial sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Device related sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Urosepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      163
    term
    Urinary tract infection
  11. 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
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      163
    term
    Pyelonephritis acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      165
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      158
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      163
    term
    Gastroenteritis
time Frame
Adverse events were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 49 weeks.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice