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NCT01271712 · ADVERSE EVENTS

Adverse events

Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST) · Source last updated 2021-01-29

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 administration of treatment till 30 days after last dose of treatment.
Other-event reporting threshold
5%

At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\>1 year".

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Regorafenib (Double Blind Only)

Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks

23 / 4140 / 4140 / 41
Placebo (Double Blind Only)

Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks

8 / 87 / 87 / 8
Placebo, Open Label Only (Switch to Regorafenib)

Participants switched to Open-label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks

31 / 5858 / 5847 / 58
Treated With Regorafenib at Any Time

Treated with Regorafenib at any time: At any time, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks

103 / 190189 / 190155 / 190
Treated With Regorafenib for > 1 Year

Treated with Regorafenib for \> 1 year: For more than a year, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks

39 / 7575 / 7548 / 75

Group identifiers: EG000: Regorafenib (Double Blind Only) · EG001: Placebo (Double Blind Only) · EG002: Placebo, Open Label Only (Switch to Regorafenib) · EG003: Treated With Regorafenib at Any Time · EG004: Treated With Regorafenib for > 1 Year

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Vertigo
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      190
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Anemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Congenital, familial and genetic disorders - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      190
      num Events
      7
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      75
      num Events
      6
    term
    Acute coronary syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      2
    term
    Chest pain - cardiac
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Conduction disorder
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Heart failure
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Cardiac disorders - Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      2
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      190
      num Events
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Anal fistula

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      190
      num Events
      7
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      75
      num Events
      5
    term
    Hearing impaired
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
      num Events
      4
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      190
      num Events
      7
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      75
      num Events
      4
    term
    Ear and labyrinth disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      58
      num Events
      25
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      190
      num Events
      77
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      75
      num Events
      35
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      190
      num Events
      17
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      75
      num Events
      9
    term
    Blood and lymphatic system disorders - Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      58
      num Events
      6
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      190
      num Events
      50
    5. group Id
      EG004
      num Affected
      25
      num At Risk
      75
      num Events
      32
    term
    Hypothyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      41
      num Events
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      58
      num Events
      23
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      190
      num Events
      122
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      75
      num Events
      60
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      190
      num Events
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      3
    term
    Ascites
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      190
      num Events
      10
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      75
      num Events
      9
    term
    Bloating
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      41
      num Events
      14
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      6
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      58
      num Events
      30
    4. group Id
      EG003
      num Affected
      63
      num At Risk
      190
      num Events
      101
    5. group Id
      EG004
      num Affected
      28
      num At Risk
      75
      num Events
      52
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
      num Events
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      58
      num Events
      67
    4. group Id
      EG003
      num Affected
      96
      num At Risk
      190
      num Events
      353
    5. group Id
      EG004
      num Affected
      53
      num At Risk
      75
      num Events
      281
    term
    Diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      58
      num Events
      9
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      190
      num Events
      39
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      75
      num Events
      30
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      58
      num Events
      6
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      190
      num Events
      16
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      75
      num Events
      6
    term
    Dry mouth
Complete source fields
description
At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\>1 year".
event Groups
  1. deaths Num Affected
    40
    deaths Num At Risk
    41
    description
    Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    41
    serious Num Affected
    23
    serious Num At Risk
    41
    title
    Regorafenib (Double Blind Only)
  2. deaths Num Affected
    7
    deaths Num At Risk
    8
    description
    Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    8
    serious Num At Risk
    8
    title
    Placebo (Double Blind Only)
  3. deaths Num Affected
    47
    deaths Num At Risk
    58
    description
    Participants switched to Open-label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks
    id
    EG002
    other Num Affected
    58
    other Num At Risk
    58
    serious Num Affected
    31
    serious Num At Risk
    58
    title
    Placebo, Open Label Only (Switch to Regorafenib)
  4. deaths Num Affected
    155
    deaths Num At Risk
    190
    description
    Treated with Regorafenib at any time: At any time, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    EG003
    other Num Affected
    189
    other Num At Risk
    190
    serious Num Affected
    103
    serious Num At Risk
    190
    title
    Treated With Regorafenib at Any Time
  5. deaths Num Affected
    48
    deaths Num At Risk
    75
    description
    Treated with Regorafenib for \> 1 year: For more than a year, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    EG004
    other Num Affected
    75
    other Num At Risk
    75
    serious Num Affected
    39
    serious Num At Risk
    75
    title
    Treated With Regorafenib for > 1 Year
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      190
      num Events
      7
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      75
      num Events
      5
    term
    Hearing impaired
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
      num Events
      4
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      190
      num Events
      7
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      75
      num Events
      4
    term
    Ear and labyrinth disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      58
      num Events
      25
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      190
      num Events
      77
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      75
      num Events
      35
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      190
      num Events
      17
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      75
      num Events
      9
    term
    Blood and lymphatic system disorders - Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      58
      num Events
      6
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      190
      num Events
      50
    5. group Id
      EG004
      num Affected
      25
      num At Risk
      75
      num Events
      32
    term
    Hypothyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      41
      num Events
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      58
      num Events
      23
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      190
      num Events
      122
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      75
      num Events
      60
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      190
      num Events
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      3
    term
    Ascites
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      190
      num Events
      10
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      75
      num Events
      9
    term
    Bloating
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      41
      num Events
      14
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      6
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      58
      num Events
      30
    4. group Id
      EG003
      num Affected
      63
      num At Risk
      190
      num Events
      101
    5. group Id
      EG004
      num Affected
      28
      num At Risk
      75
      num Events
      52
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
      num Events
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      58
      num Events
      67
    4. group Id
      EG003
      num Affected
      96
      num At Risk
      190
      num Events
      353
    5. group Id
      EG004
      num Affected
      53
      num At Risk
      75
      num Events
      281
    term
    Diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      58
      num Events
      9
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      190
      num Events
      39
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      75
      num Events
      30
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      58
      num Events
      6
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      190
      num Events
      16
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      75
      num Events
      6
    term
    Dry mouth
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Vertigo
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      190
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Anemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Congenital, familial and genetic disorders - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      190
      num Events
      7
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      75
      num Events
      6
    term
    Acute coronary syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      2
    term
    Chest pain - cardiac
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Conduction disorder
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Heart failure
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      75
      num Events
      0
    term
    Cardiac disorders - Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      2
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      190
      num Events
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      190
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      75
      num Events
      1
    term
    Anal fistula
time Frame
From first administration of treatment till 30 days after last dose of treatment.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice