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NCT03375320 · ADVERSE EVENTS

Adverse events

Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors · Source last updated 2026-08-04

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
60 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])

Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> * Cabozantinib S-malate: Given PO \> * Computed Tomography: Undergo CT \> * Magnetic Resonance Imaging: Undergo MRI \> * Quality-of-Life Assessment: Ancillary studies \> * X-Ray Imaging: Undergo x-ray

89 / 134134 / 13460 / 134
Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])

Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> * Computed Tomography: Undergo CT \> * Magnetic Resonance Imaging: Undergo MRI \> * Placebo Administration: Given PO \> * Quality-of-Life Assessment: Ancillary studies \> * X-Ray Imaging: Undergo x-ray

41 / 6969 / 6937 / 69
Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])

Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> * Cabozantinib S-malate: Given PO \> * Computed Tomography: Undergo CT \> * Magnetic Resonance Imaging: Undergo MRI \> * Quality-of-Life Assessment: Ancillary studies \> * X-Ray Imaging: Undergo x-ray

49 / 6464 / 6421 / 64
Arm IIb (Placebo, Pancreatic NET Cohort [pNET])

Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> * Computed Tomography: Undergo CT \> * Magnetic Resonance Imaging: Undergo MRI \> * Placebo Administration: Given PO \> * Quality-of-Life Assessment: Ancillary studies \> * X-Ray Imaging: Undergo x-ray

21 / 3131 / 3111 / 31

Group identifiers: EG000: Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) · EG001: Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) · EG002: Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) · EG003: Arm IIb (Placebo, Pancreatic NET Cohort [pNET])

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      134
      num Events
      9
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      69
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      64
      num Events
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Acute intestinal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      69
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Acute kidney injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Acute Metabolic Encephalopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      134
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      69
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      64
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alkaline phosphatase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      134
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alkalosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anal fissure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      134
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      134
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      64
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anxiety

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      134
      num Events
      159
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      69
      num Events
      48
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      64
      num Events
      75
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
      num Events
      14
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Acidosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      134
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      64
      num Events
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Activated partial throm time prolonged
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Agitation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      134
      num Events
      455
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      69
      num Events
      31
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      64
      num Events
      355
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      31
      num Events
      29
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      134
      num Events
      186
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      69
      num Events
      50
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      64
      num Events
      98
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      31
      num Events
      32
    term
    Alkaline phosphatase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Allergic reaction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      134
      num Events
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      64
      num Events
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Allergic rhinitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      134
      num Events
      93
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      64
      num Events
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anal fissure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anal fistula
Complete source fields
event Groups
  1. deaths Num Affected
    60
    deaths Num At Risk
    134
    description
    Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> * Cabozantinib S-malate: Given PO \> * Computed Tomography: Undergo CT \> * Magnetic Resonance Imaging: Undergo MRI \> * Quality-of-Life Assessment: Ancillary studies \> * X-Ray Imaging: Undergo x-ray
    id
    EG000
    other Num Affected
    134
    other Num At Risk
    134
    serious Num Affected
    89
    serious Num At Risk
    134
    title
    Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
  2. deaths Num Affected
    37
    deaths Num At Risk
    69
    description
    Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> * Computed Tomography: Undergo CT \> * Magnetic Resonance Imaging: Undergo MRI \> * Placebo Administration: Given PO \> * Quality-of-Life Assessment: Ancillary studies \> * X-Ray Imaging: Undergo x-ray
    id
    EG001
    other Num Affected
    69
    other Num At Risk
    69
    serious Num Affected
    41
    serious Num At Risk
    69
    title
    Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
  3. deaths Num Affected
    21
    deaths Num At Risk
    64
    description
    Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> * Cabozantinib S-malate: Given PO \> * Computed Tomography: Undergo CT \> * Magnetic Resonance Imaging: Undergo MRI \> * Quality-of-Life Assessment: Ancillary studies \> * X-Ray Imaging: Undergo x-ray
    id
    EG002
    other Num Affected
    64
    other Num At Risk
    64
    serious Num Affected
    49
    serious Num At Risk
    64
    title
    Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
  4. deaths Num Affected
    11
    deaths Num At Risk
    31
    description
    Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> * Computed Tomography: Undergo CT \> * Magnetic Resonance Imaging: Undergo MRI \> * Placebo Administration: Given PO \> * Quality-of-Life Assessment: Ancillary studies \> * X-Ray Imaging: Undergo x-ray
    id
    EG003
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    21
    serious Num At Risk
    31
    title
    Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      134
      num Events
      159
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      69
      num Events
      48
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      64
      num Events
      75
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
      num Events
      14
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Acidosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      134
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      64
      num Events
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Activated partial throm time prolonged
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Agitation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      134
      num Events
      455
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      69
      num Events
      31
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      64
      num Events
      355
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      31
      num Events
      29
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      134
      num Events
      186
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      69
      num Events
      50
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      64
      num Events
      98
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      31
      num Events
      32
    term
    Alkaline phosphatase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Allergic reaction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      134
      num Events
      62
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      64
      num Events
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Allergic rhinitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      134
      num Events
      93
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      64
      num Events
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anal fissure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anal fistula
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      134
      num Events
      9
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      69
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      64
      num Events
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Acute intestinal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      69
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Acute kidney injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Acute Metabolic Encephalopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      69
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      134
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      69
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      64
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alkaline phosphatase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      134
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Alkalosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anal fissure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      134
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      64
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      134
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      64
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      134
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      69
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      64
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    term
    Anxiety
time Frame
60 months

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Preserved source evidence · Not medical advice