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NCT01875237 · ADVERSE EVENTS

Adverse events

Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene · Source last updated 2019-07-16

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 30 days after DLI or after AP1903 infusion, whichever is later
Other-event reporting threshold
0%

Adverse events were captured for patients who received DLI and AP1903.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Transplant Only

Patients who did not move forward to DLI

0 / 00 / 00 / 0
Transplat Plus DLI

Proceeded to DLI per protocol

1 / 11 / 11 / 1

Group identifiers: EG000: Transplant Only · EG001: Transplat Plus DLI

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    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
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Elevated creatinine
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Infection (CMV)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Infection (adenovirus)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Infection (E.Coli)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Skin Rash
Complete source fields
description
Adverse events were captured for patients who received DLI and AP1903.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Patients who did not move forward to DLI
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Transplant Only
  2. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Proceeded to DLI per protocol
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Transplat Plus DLI
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Elevated creatinine
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Infection (CMV)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Infection (adenovirus)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Infection (E.Coli)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Skin Rash
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Infection
time Frame
up to 30 days after DLI or after AP1903 infusion, whichever is later

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice