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NCT01716806 · ADVERSE EVENTS

Adverse events

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-06-11

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
Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
Other-event reporting threshold
5%

The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A

Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.

5 / 2727 / 2713 / 27
Part B

BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.

4 / 2222 / 229 / 22
Part C

BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.

13 / 2020 / 2012 / 20
Part D

BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

4 / 2121 / 214 / 21
Part E

BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

14 / 3027 / 3010 / 30
Part F

BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.

4 / 77 / 75 / 7

Group identifiers: EG000: Part A · EG001: Part B · EG002: Part C · EG003: Part D · EG004: Part E · EG005: Part F

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 v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Atrial flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Inappropriate antidiuretic hormone secretion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal pain

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 v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
      num Events
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypoacusis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Eye irritation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      21
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      27
      num Events
      9
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      22
      num Events
      12
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      20
      num Events
      7
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      21
      num Events
      11
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      30
      num Events
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Constipation
Complete source fields
description
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
event Groups
  1. deaths Num Affected
    13
    deaths Num At Risk
    27
    description
    Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
    id
    EG000
    other Num Affected
    27
    other Num At Risk
    27
    serious Num Affected
    5
    serious Num At Risk
    27
    title
    Part A
  2. deaths Num Affected
    9
    deaths Num At Risk
    22
    description
    BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    4
    serious Num At Risk
    22
    title
    Part B
  3. deaths Num Affected
    12
    deaths Num At Risk
    20
    description
    BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
    id
    EG002
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    13
    serious Num At Risk
    20
    title
    Part C
  4. deaths Num Affected
    4
    deaths Num At Risk
    21
    description
    BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    EG003
    other Num Affected
    21
    other Num At Risk
    21
    serious Num Affected
    4
    serious Num At Risk
    21
    title
    Part D
  5. deaths Num Affected
    10
    deaths Num At Risk
    30
    description
    BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    EG004
    other Num Affected
    27
    other Num At Risk
    30
    serious Num Affected
    14
    serious Num At Risk
    30
    title
    Part E
  6. deaths Num Affected
    5
    deaths Num At Risk
    7
    description
    BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    EG005
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Part F
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
      num Events
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      7
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypoacusis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Eye irritation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      21
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      27
      num Events
      9
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      22
      num Events
      12
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      20
      num Events
      7
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      21
      num Events
      11
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      30
      num Events
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Atrial flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Inappropriate antidiuretic hormone secretion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal pain
time Frame
Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months

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Preserved source evidence · Not medical advice