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NCT05014412 · ADVERSE EVENTS

Adverse events

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment · Source last updated 2026-02-10

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
Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
Other-event reporting threshold
5%

Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-cause mortality: number of deaths are reported from Day 1 of the study up to 90 days post last dose and deaths which occurred after 90 days post last dose of study drug are also included.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1

Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for \>= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

23 / 3333 / 3313 / 33
Part 2A: Dose Level 1

Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

11 / 1212 / 128 / 12
Part 2A: Dose Level 2

Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

8 / 1110 / 114 / 11
Part 2B

Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

21 / 2928 / 298 / 29

Group identifiers: EG000: Part 1 · EG001: Part 2A: Dose Level 1 · EG002: Part 2A: Dose Level 2 · EG003: Part 2B

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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      29
    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
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    term
    Deafness bilateral
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Diarrhoea
  6. 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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Enterocolitis
  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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Food poisoning
  8. 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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    term
    Gastrointestinal haemorrhage
  9. 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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Asthenia
  10. 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
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    term
    Chest pain
  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
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    term
    Chills
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      29
    term
    Disease progression

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
      15
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      29
    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
      10
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      29
    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
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      29
    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
      19
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      29
    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
      6
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      29
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      29
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      29
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      29
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      29
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      29
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Influenza like illness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      29
    term
    Injection site erythema
Complete source fields
description
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-cause mortality: number of deaths are reported from Day 1 of the study up to 90 days post last dose and deaths which occurred after 90 days post last dose of study drug are also included.
event Groups
  1. deaths Num Affected
    13
    deaths Num At Risk
    33
    description
    Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for \>= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    23
    serious Num At Risk
    33
    title
    Part 1
  2. deaths Num Affected
    8
    deaths Num At Risk
    12
    description
    Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    11
    serious Num At Risk
    12
    title
    Part 2A: Dose Level 1
  3. deaths Num Affected
    4
    deaths Num At Risk
    11
    description
    Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    11
    serious Num Affected
    8
    serious Num At Risk
    11
    title
    Part 2A: Dose Level 2
  4. deaths Num Affected
    8
    deaths Num At Risk
    29
    description
    Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
    id
    EG003
    other Num Affected
    28
    other Num At Risk
    29
    serious Num Affected
    21
    serious Num At Risk
    29
    title
    Part 2B
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
      15
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      29
    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
      10
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      29
    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
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      29
    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
      19
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      29
    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
      6
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      29
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      29
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      29
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      29
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      29
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      29
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Influenza like illness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      29
    term
    Injection site erythema
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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      29
    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
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    term
    Deafness bilateral
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Diarrhoea
  6. 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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Enterocolitis
  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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Food poisoning
  8. 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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    term
    Gastrointestinal haemorrhage
  9. 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
      33
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      29
    term
    Asthenia
  10. 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
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    term
    Chest pain
  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
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      29
    term
    Chills
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      29
    term
    Disease progression
time Frame
Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)

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Preserved source evidence · Not medical advice