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NCT03269136 · ADVERSE EVENTS

Adverse events

PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma · Source last updated 2025-03-18

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
Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months
Other-event reporting threshold
5%

Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: PF-06863135 0.1 mcg/kg IV

Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

0 / 22 / 22 / 2
Part 1: PF-06863135 0.3 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

1 / 33 / 32 / 3
Part 1: PF-06863135 1 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

0 / 22 / 22 / 2
Part 1: PF-06863135 3 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

3 / 33 / 33 / 3
Part 1: PF-06863135 10 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

0 / 22 / 22 / 2
Part 1: PF-06863135 30 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

2 / 55 / 54 / 5
Part 1: PF-06863135 50 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

5 / 66 / 64 / 6
Part 1: PF-06863135 80 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

4 / 66 / 65 / 6
Part 1: PF-06863135 130 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

1 / 44 / 41 / 4
Part 1: PF-06863135 215 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

3 / 44 / 43 / 4
Part 1: PF-06863135 360 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

3 / 44 / 43 / 4
Part 1: PF-06863135 600 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

4 / 66 / 63 / 6
Part 1: PF-06863135 1000 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

5 / 66 / 62 / 6
Part 1.1: PF-06863135 Priming Cohort Q1W SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

6 / 77 / 73 / 7
Part 1.1: PF-06863135 Priming Cohort Q2W SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

9 / 1313 / 134 / 13
Part 1C: PF-06863135 + Lenalidomide SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

2 / 44 / 42 / 4
Part 1D: PF-06863135 + Pomalidomide SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

8 / 99 / 94 / 9
Part 2A: PF-06863135 SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

12 / 1513 / 1510 / 15
Part 1: PF-06863135 Total IV

Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

11 / 2323 / 2319 / 23
Part 1: PF-06863135 Total SC

Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

20 / 3030 / 3017 / 30
Part 1.1: PF-06863135 Total SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

15 / 2020 / 207 / 20

Group identifiers: EG000: Part 1: PF-06863135 0.1 mcg/kg IV · EG001: Part 1: PF-06863135 0.3 mcg/kg IV · EG002: Part 1: PF-06863135 1 mcg/kg IV · EG003: Part 1: PF-06863135 3 mcg/kg IV · EG004: Part 1: PF-06863135 10 mcg/kg IV · EG005: Part 1: PF-06863135 30 mcg/kg IV · EG006: Part 1: PF-06863135 50 mcg/kg IV · EG007: Part 1: PF-06863135 80 mcg/kg SC · EG008: Part 1: PF-06863135 130 mcg/kg SC · EG009: Part 1: PF-06863135 215 mcg/kg SC · EG010: Part 1: PF-06863135 360 mcg/kg SC · EG011: Part 1: PF-06863135 600 mcg/kg SC · EG012: Part 1: PF-06863135 1000 mcg/kg SC · EG013: Part 1.1: PF-06863135 Priming Cohort Q1W SC · EG014: Part 1.1: PF-06863135 Priming Cohort Q2W SC · EG015: Part 1C: PF-06863135 + Lenalidomide SC · EG016: Part 1D: PF-06863135 + Pomalidomide SC · EG017: Part 2A: PF-06863135 SC · EG018: Part 1: PF-06863135 Total IV · EG019: Part 1: PF-06863135 Total SC · EG020: Part 1.1: PF-06863135 Total SC

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Atrial flutter
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Supraventricular tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Adrenal insufficiency
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Diplopia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Extraocular muscle disorder
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Colitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      6
    term
    Diarrhoea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      6
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      6
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      6
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      6
    term
    Sinus tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      6
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      6
    term
    Chills
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      6
    term
    Fatigue
Complete source fields
description
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Part 1: PF-06863135 0.1 mcg/kg IV
  2. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part 1: PF-06863135 0.3 mcg/kg IV
  3. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Part 1: PF-06863135 1 mcg/kg IV
  4. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Part 1: PF-06863135 3 mcg/kg IV
  5. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Part 1: PF-06863135 10 mcg/kg IV
  6. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Part 1: PF-06863135 30 mcg/kg IV
  7. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG006
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Part 1: PF-06863135 50 mcg/kg IV
  8. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG007
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Part 1: PF-06863135 80 mcg/kg SC
  9. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG008
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Part 1: PF-06863135 130 mcg/kg SC
  10. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG009
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Part 1: PF-06863135 215 mcg/kg SC
  11. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG010
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Part 1: PF-06863135 360 mcg/kg SC
  12. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    EG011
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Part 1: PF-06863135 600 mcg/kg SC
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      6
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      6
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      6
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      6
    term
    Sinus tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      6
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      6
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      6
    term
    Chills
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      6
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Atrial flutter
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Supraventricular tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Adrenal insufficiency
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Diplopia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Extraocular muscle disorder
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      6
    term
    Colitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      4
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      6
    term
    Diarrhoea
time Frame
Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months

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Preserved source evidence · Not medical advice