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NCT04213209 · ADVERSE EVENTS

Adverse events

Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma" · Source last updated 2024-09-27

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
Up to 12 Months
Other-event reporting threshold
5.0%

At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Adult Participants With PTCL-NOS

Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

8 / 3118 / 311 / 31
Adult Participants With AITL

Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

12 / 3514 / 355 / 35
Adult Participants With ATLL

Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

2 / 146 / 142 / 14
Adult Participants With Other PTCL

Adult participants with the other PTCL (peripheral T-cell lymphoma \[PTCL\] subtypes other than anaplastic large-cell lymphoma \[ALCL\] \[not surveyed\], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

1 / 64 / 60 / 6
Pediatric Participants With PTCL

Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

3 / 42 / 40 / 4
Pediatric Participants With HL

Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

2 / 42 / 40 / 4

Group identifiers: EG000: Adult Participants With PTCL-NOS · EG001: Adult Participants With AITL · EG002: Adult Participants With ATLL · EG003: Adult Participants With Other PTCL · EG004: Pediatric Participants With PTCL · EG005: Pediatric Participants With HL

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
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    term
    Vascular device infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Angioimmunoblastic T-cell lymphoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Peripheral T-cell lymphoma unspecified
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Metastases to central nervous system
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    term
    Myelosuppression
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Pancytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Diabetes mellitus

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
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    term
    Otitis media acute
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    term
    Upper respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Hyponatraemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Peripheral motor neuropathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Peripheral sensory neuropathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    VIth nerve disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Cholelithiasis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Rash
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Rash papular
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Pruritus allergic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Malaise
Complete source fields
description
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    31
    description
    Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    31
    serious Num Affected
    8
    serious Num At Risk
    31
    title
    Adult Participants With PTCL-NOS
  2. deaths Num Affected
    5
    deaths Num At Risk
    35
    description
    Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    EG001
    other Num Affected
    14
    other Num At Risk
    35
    serious Num Affected
    12
    serious Num At Risk
    35
    title
    Adult Participants With AITL
  3. deaths Num Affected
    2
    deaths Num At Risk
    14
    description
    Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    14
    serious Num Affected
    2
    serious Num At Risk
    14
    title
    Adult Participants With ATLL
  4. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Adult participants with the other PTCL (peripheral T-cell lymphoma \[PTCL\] subtypes other than anaplastic large-cell lymphoma \[ALCL\] \[not surveyed\], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Adult Participants With Other PTCL
  5. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Pediatric Participants With PTCL
  6. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Pediatric Participants With HL
frequency Threshold
5.0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    term
    Otitis media acute
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    term
    Upper respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Hyponatraemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Peripheral motor neuropathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Peripheral sensory neuropathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    VIth nerve disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Cholelithiasis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Rash
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Rash papular
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Pruritus allergic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Malaise
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    term
    Vascular device infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Angioimmunoblastic T-cell lymphoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Peripheral T-cell lymphoma unspecified
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Metastases to central nervous system
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    term
    Myelosuppression
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Pancytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA/J v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    term
    Diabetes mellitus
time Frame
Up to 12 Months

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Preserved source evidence · Not medical advice