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NCT05316701 · ADVERSE EVENTS

Adverse events

Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies · Source last updated 2026-03-04

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
A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).
Other-event reporting threshold
5%

Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Orca-T

Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus

34 / 8888 / 883 / 88
Standard of Care

Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate

53 / 9494 / 949 / 94

Group identifiers: EG000: Orca-T · EG001: Standard of Care

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 v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      94
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      94
    term
    Bacterial sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      94
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      94
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      94
    term
    Staphylococcal sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Adenovirus infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Appendicitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    COVID-19 pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Device related infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Influenza
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Rhinovirus infection

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 v27.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      94
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      94
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      94
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      94
    term
    Stomatitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      94
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      94
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      94
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      94
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      94
    term
    Oesophagitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      94
    term
    Haemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      94
    term
    Proctalgia
Complete source fields
description
Safety Analysis Set: Participants in the ITT analysis set who received either Orca-T or SoC, analyzed according to treatment received
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    88
    description
    Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
    id
    EG000
    other Num Affected
    88
    other Num At Risk
    88
    serious Num Affected
    34
    serious Num At Risk
    88
    title
    Orca-T
  2. deaths Num Affected
    9
    deaths Num At Risk
    94
    description
    Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
    id
    EG001
    other Num Affected
    94
    other Num At Risk
    94
    serious Num Affected
    53
    serious Num At Risk
    94
    title
    Standard of Care
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      94
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      94
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      94
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      94
    term
    Stomatitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      94
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      94
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      94
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      94
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      94
    term
    Oesophagitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      94
    term
    Haemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      94
    term
    Proctalgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      94
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      94
    term
    Bacterial sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      94
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      94
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      94
    term
    Staphylococcal sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Adenovirus infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Appendicitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    COVID-19 pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Device related infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Influenza
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Rhinovirus infection
time Frame
A treatment-emergent AE (TEAE) was any AE that started on or after alloHCT infusion (Orca-T or SoC) through study completion (day +730).

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