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NCT00984282 · ADVERSE EVENTS

Adverse events

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer · Source last updated 2018-09-13

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
After signing the informed consent until the database cut-off 30 AUG 2017, study duration approximately eight years.
Other-event reporting threshold
5%

Abbreviations used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Cranial Nerve (CN), Range of Motion (ROM), Cerebrospinal Fluid (CSF), Genitourinary (GU).

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

Reporting Group 1: Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double blind period

87 / 207202 / 20771 / 207
Placebo (Double Blind Only)

Reporting Group 2: Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double-blind period.

58 / 209173 / 20925 / 209
Sorafenib, Open Label Only (Sorafenib Continued)

Reporting Group 3: Participants on sorafenib who continued OL sorafenib treat., received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of OL period to the data cutoff on 31 Aug

51 / 8674 / 8638 / 86
Placebo, Open Label Only (Switch to Sorafenib)

Reporting Group 3: Participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of open label period to the data cutoff on 31 Aug 20

96 / 161159 / 16190 / 161

Group identifiers: EG000: Sorafenib (Double Blind Only) · EG001: Placebo (Double Blind Only) · EG002: Sorafenib, Open Label Only (Sorafenib Continued) · EG003: Placebo, Open Label Only (Switch to Sorafenib)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      161
      num Events
      1
    term
    Blood - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      207
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      161
      num Events
      5
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      161
      num Events
      1
    term
    Lymphatics - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      207
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Neutrophils
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      207
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      209
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Cardiac arrhythmia - Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      207
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      161
      num Events
      4
    term
    Cardiac general - Other
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      207
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      161
      num Events
      4
    term
    Cardiac ischemia/infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      207
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Cardiopulmonary arrest
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      161
      num Events
      1
    term
    Pericardial effusion
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      209
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      161
      num Events
      1
    term
    Supraventricular arrhythmia, Atrial fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Supraventricular arrhythmia, Atrial flutter
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      207
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Supraventricular arrhythmia, Supraventricular tachycardia

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      207
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      209
      num Events
      10
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      86
      num Events
      20
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      161
      num Events
      23
    term
    Blood - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      207
      num Events
      17
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      209
      num Events
      7
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      86
      num Events
      9
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      161
      num Events
      11
    term
    Edema: Limb
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      207
      num Events
      24
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      209
      num Events
      11
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      86
      num Events
      9
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      161
      num Events
      32
    term
    Hemoglobin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      207
      num Events
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      209
      num Events
      8
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      86
      num Events
      6
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      161
      num Events
      15
    term
    Leukocytes
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      207
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      209
      num Events
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      161
      num Events
      13
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      207
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      209
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      86
      num Events
      4
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      161
      num Events
      15
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      207
      num Events
      103
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      209
      num Events
      35
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      86
      num Events
      13
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      161
      num Events
      57
    term
    Hypertension
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      207
      num Events
      89
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      209
      num Events
      12
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      86
      num Events
      9
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      161
      num Events
      52
    term
    Anorexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      207
      num Events
      38
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      209
      num Events
      19
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      86
      num Events
      4
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      161
      num Events
      29
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      207
      num Events
      226
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      209
      num Events
      40
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      86
      num Events
      26
    4. group Id
      EG003
      num Affected
      96
      num At Risk
      161
      num Events
      165
    term
    Diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      207
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      209
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
      num Events
      2
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      161
      num Events
      7
    term
    Dry mouth
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      207
      num Events
      17
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      209
      num Events
      9
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      86
      num Events
      7
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      161
      num Events
      14
    term
    Dysphagia
Complete source fields
description
Abbreviations used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Cranial Nerve (CN), Range of Motion (ROM), Cerebrospinal Fluid (CSF), Genitourinary (GU).
event Groups
  1. deaths Num Affected
    71
    deaths Num At Risk
    207
    description
    Reporting Group 1: Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double blind period
    id
    EG000
    other Num Affected
    202
    other Num At Risk
    207
    serious Num Affected
    87
    serious Num At Risk
    207
    title
    Sorafenib (Double Blind Only)
  2. deaths Num Affected
    25
    deaths Num At Risk
    209
    description
    Reporting Group 2: Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double-blind period.
    id
    EG001
    other Num Affected
    173
    other Num At Risk
    209
    serious Num Affected
    58
    serious Num At Risk
    209
    title
    Placebo (Double Blind Only)
  3. deaths Num Affected
    38
    deaths Num At Risk
    86
    description
    Reporting Group 3: Participants on sorafenib who continued OL sorafenib treat., received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of OL period to the data cutoff on 31 Aug
    id
    EG002
    other Num Affected
    74
    other Num At Risk
    86
    serious Num Affected
    51
    serious Num At Risk
    86
    title
    Sorafenib, Open Label Only (Sorafenib Continued)
  4. deaths Num Affected
    90
    deaths Num At Risk
    161
    description
    Reporting Group 3: Participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of open label period to the data cutoff on 31 Aug 20
    id
    EG003
    other Num Affected
    159
    other Num At Risk
    161
    serious Num Affected
    96
    serious Num At Risk
    161
    title
    Placebo, Open Label Only (Switch to Sorafenib)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      207
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      209
      num Events
      10
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      86
      num Events
      20
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      161
      num Events
      23
    term
    Blood - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      207
      num Events
      17
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      209
      num Events
      7
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      86
      num Events
      9
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      161
      num Events
      11
    term
    Edema: Limb
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      207
      num Events
      24
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      209
      num Events
      11
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      86
      num Events
      9
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      161
      num Events
      32
    term
    Hemoglobin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      207
      num Events
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      209
      num Events
      8
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      86
      num Events
      6
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      161
      num Events
      15
    term
    Leukocytes
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      207
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      209
      num Events
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      161
      num Events
      13
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      207
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      209
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      86
      num Events
      4
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      161
      num Events
      15
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      207
      num Events
      103
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      209
      num Events
      35
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      86
      num Events
      13
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      161
      num Events
      57
    term
    Hypertension
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      207
      num Events
      89
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      209
      num Events
      12
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      86
      num Events
      9
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      161
      num Events
      52
    term
    Anorexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      207
      num Events
      38
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      209
      num Events
      19
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      86
      num Events
      4
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      161
      num Events
      29
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      207
      num Events
      226
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      209
      num Events
      40
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      86
      num Events
      26
    4. group Id
      EG003
      num Affected
      96
      num At Risk
      161
      num Events
      165
    term
    Diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      207
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      209
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
      num Events
      2
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      161
      num Events
      7
    term
    Dry mouth
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      207
      num Events
      17
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      209
      num Events
      9
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      86
      num Events
      7
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      161
      num Events
      14
    term
    Dysphagia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      161
      num Events
      1
    term
    Blood - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      207
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      161
      num Events
      5
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      161
      num Events
      1
    term
    Lymphatics - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      207
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Neutrophils
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      207
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      209
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Cardiac arrhythmia - Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      207
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      161
      num Events
      4
    term
    Cardiac general - Other
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      207
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      161
      num Events
      4
    term
    Cardiac ischemia/infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      207
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Cardiopulmonary arrest
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      86
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      161
      num Events
      1
    term
    Pericardial effusion
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      209
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      161
      num Events
      1
    term
    Supraventricular arrhythmia, Atrial fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      207
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      86
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Supraventricular arrhythmia, Atrial flutter
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      207
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      209
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      86
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      161
      num Events
      0
    term
    Supraventricular arrhythmia, Supraventricular tachycardia
time Frame
After signing the informed consent until the database cut-off 30 AUG 2017, study duration approximately eight years.

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

Preserved source evidence · Not medical advice