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NCT05140382 · ADVERSE EVENTS

Adverse events

AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL · Source last updated 2024-08-28

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 treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1 Non-NK PTCL

Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.

21 / 3131 / 3117 / 31
Cohort 2 NK PTCL

Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.

2 / 22 / 21 / 2
Cohort 3 cHL

Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.

11 / 1918 / 192 / 19

Group identifiers: EG000: Cohort 1 Non-NK PTCL · EG001: Cohort 2 NK PTCL · EG002: Cohort 3 cHL

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
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    COVID-19
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Escherichia sepsis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Herpes zoster disseminated
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Pneumonia viral
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Staphylococcal bacteraemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Staphylococcal sepsis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Streptococcal sepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      19
      num Events
      3
    term
    Febrile neutropenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Leukopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      2
    term
    Neutropenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Hyponatraemia

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
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Bacteraemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    COVID-19
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Catheter site infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Enterobacter bacteraemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Enterococcal infection
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Herpes zoster
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Influenza
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Pneumonia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Streptococcal infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      19
      num Events
      3
    term
    Upper respiratory tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Urinary tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Vascular device infection
Complete source fields
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    31
    description
    Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    21
    serious Num At Risk
    31
    title
    Cohort 1 Non-NK PTCL
  2. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Cohort 2 NK PTCL
  3. deaths Num Affected
    2
    deaths Num At Risk
    19
    description
    Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
    id
    EG002
    other Num Affected
    18
    other Num At Risk
    19
    serious Num Affected
    11
    serious Num At Risk
    19
    title
    Cohort 3 cHL
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Bacteraemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    COVID-19
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Catheter site infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Enterobacter bacteraemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Enterococcal infection
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Herpes zoster
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Influenza
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Pneumonia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Streptococcal infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      19
      num Events
      3
    term
    Upper respiratory tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Urinary tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Vascular device infection
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    COVID-19
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Escherichia sepsis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Herpes zoster disseminated
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Pneumonia viral
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Staphylococcal bacteraemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Staphylococcal sepsis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Streptococcal sepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      19
      num Events
      3
    term
    Febrile neutropenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Leukopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      2
    term
    Neutropenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Hyponatraemia
time Frame
From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).

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Preserved source evidence · Not medical advice