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NCT02481934 · ADVERSE EVENTS

Adverse events

Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma · Source last updated 2021-08-20

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
4 months during treatment with NKAE cells.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
NKAE Cells Infusion + Chemotherapy

Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib). NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle. Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles. Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.

2 / 52 / 5Not reported / Not reported

Group identifiers: EG000: NKAE Cells Infusion + Chemotherapy

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
    notes
    The patient was suffering for gastrointestinal bleeding before enrollment.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Gastrointestinal bleeding
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    This serious adverse event was due to multiple myeloma bone lesions.
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      2
    term
    Vertebral compression

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
    notes
    Two patients had grade II neutropenia but none of them need dose adjustment.
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Neutropenia
Complete source fields
event Groups
  1. description
    Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib). NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle. Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles. Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    NKAE Cells Infusion + Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Two patients had grade II neutropenia but none of them need dose adjustment.
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Neutropenia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    The patient was suffering for gastrointestinal bleeding before enrollment.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Gastrointestinal bleeding
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    This serious adverse event was due to multiple myeloma bone lesions.
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      2
    term
    Vertebral compression
time Frame
4 months during treatment with NKAE cells.

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

Preserved source evidence · Not medical advice