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NCT00474929 · ADVERSE EVENTS

Adverse events

Sorafenib and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma · Source last updated 2019-08-20

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
The adverse events reported here occurred during treatment. The maximum treatment length was 27, 28-day cycles.
Other-event reporting threshold
0%

Adverse events were collected at the end of each cycle.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I, Dose Level 0

Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day

2 / 66 / 6Not reported / Not reported
Phase I, Dose Level 1

Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day

1 / 55 / 5Not reported / Not reported
Phase I, Dose Level 2

Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day

2 / 55 / 5Not reported / Not reported
Phase I, Dose Level 3

Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day

1 / 55 / 5Not reported / Not reported
Phase II

Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;

22 / 7776 / 77Not reported / Not reported

Group identifiers: EG000: Phase I, Dose Level 0 · EG001: Phase I, Dose Level 1 · EG002: Phase I, Dose Level 2 · EG003: Phase I, Dose Level 3 · EG004: Phase II

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      77
      num Events
      3
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Cardiac valve disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      77
      num Events
      2
    term
    Ear, nose and throat examination abnormal
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Disease progression
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      77
      num Events
      2
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Fever
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Sudden death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Hypersensitivity

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      5
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
      num Events
      15
    5. group Id
      EG004
      num Affected
      31
      num At Risk
      77
      num Events
      63
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      77
      num Events
      3
    term
    Hemolysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Thrombotic microangiopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Cardiac disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Hearing loss
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Adrenal insufficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      77
      num Events
      4
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
      num Events
      10
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      5
      num Events
      20
    5. group Id
      EG004
      num Affected
      53
      num At Risk
      77
      num Events
      266
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Dry mouth
Complete source fields
description
Adverse events were collected at the end of each cycle.
event Groups
  1. description
    Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase I, Dose Level 0
  2. description
    Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Phase I, Dose Level 1
  3. description
    Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase I, Dose Level 2
  4. description
    Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Phase I, Dose Level 3
  5. description
    Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
    id
    EG004
    other Num Affected
    76
    other Num At Risk
    77
    serious Num Affected
    22
    serious Num At Risk
    77
    title
    Phase II
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      5
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
      num Events
      15
    5. group Id
      EG004
      num Affected
      31
      num At Risk
      77
      num Events
      63
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      77
      num Events
      3
    term
    Hemolysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Thrombotic microangiopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Cardiac disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Hearing loss
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Adrenal insufficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      77
      num Events
      0
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      77
      num Events
      4
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
      num Events
      10
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      5
      num Events
      20
    5. group Id
      EG004
      num Affected
      53
      num At Risk
      77
      num Events
      266
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Dry mouth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      77
      num Events
      3
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Cardiac valve disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Sinus bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      77
      num Events
      2
    term
    Ear, nose and throat examination abnormal
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Disease progression
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      77
      num Events
      2
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Fever
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Sudden death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      77
      num Events
      1
    term
    Hypersensitivity
time Frame
The adverse events reported here occurred during treatment. The maximum treatment length was 27, 28-day cycles.

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Preserved source evidence · Not medical advice