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NCT03439280 · ADVERSE EVENTS

Adverse events

A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM) · Source last updated 2023-02-24

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
From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)
Other-event reporting threshold
5%

At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg

Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

0 / 44 / 41 / 4
Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg

Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

0 / 33 / 30 / 3
Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg

Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

1 / 1212 / 127 / 12
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg

Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

8 / 2221 / 226 / 22
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg

Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

1 / 33 / 31 / 3
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex

Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.

2 / 66 / 61 / 6

Group identifiers: EG000: Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg · EG001: Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg · EG002: Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg · EG003: Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg · EG004: Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg · EG005: Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    COVID-19
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Diverticulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Influenza
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Pancreatitis acute

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abnormal loss of weight
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Agitation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Alopecia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Angina pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Anxiety
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Aspartate aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Back pain
Complete source fields
description
At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg
  3. deaths Num Affected
    7
    deaths Num At Risk
    12
    description
    Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    1
    serious Num At Risk
    12
    title
    Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
  4. deaths Num Affected
    6
    deaths Num At Risk
    22
    description
    Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
    id
    EG003
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    8
    serious Num At Risk
    22
    title
    Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
  5. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
  6. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
    id
    EG005
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abnormal loss of weight
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Agitation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Alopecia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Angina pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Anxiety
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Aspartate aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Back pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    term
    COVID-19
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Diverticulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Influenza
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    term
    Pancreatitis acute
time Frame
From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

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Preserved source evidence · Not medical advice