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NCT01292486 · ADVERSE EVENTS

Adverse events

Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure · Source last updated 2013-05-01

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
During stem cell collection (3-6 hours) and following reinfusion of collected stem cell product until neutrophil recovery (1-28 days).
Other-event reporting threshold
5%

Two participants were removed from the study before they underwent a collection on the Spectra Optia Apheresis System and were not at risk.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Patients With Multiple Myeloma

Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.

2 / 307 / 30Not reported / Not reported

Group identifiers: EG000: Patients With Multiple Myeloma

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
    notes
    Blood cultures were negative but patient was hospitalized for antibiotic administration. Patient recovered and event judged to unrelated to the device.
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Fever and hypotension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Required inpatient hospitalization and antibiotics. Patient recovered. Unrelated to the device.
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Pneumonia/Sepsis

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
      num Events
      5
    term
    Citrate Reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever post ahpheresis, pre-apheresis and product cultures negative.Patient recovered.Unrelated to the device. Fever/chills post apheresis, preapheresis blood culture positive.Patient recovered.Unrelated to the device.
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Fever
Complete source fields
description
Two participants were removed from the study before they underwent a collection on the Spectra Optia Apheresis System and were not at risk.
event Groups
  1. description
    Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    30
    serious Num Affected
    2
    serious Num At Risk
    30
    title
    Patients With Multiple Myeloma
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
      num Events
      5
    term
    Citrate Reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever post ahpheresis, pre-apheresis and product cultures negative.Patient recovered.Unrelated to the device. Fever/chills post apheresis, preapheresis blood culture positive.Patient recovered.Unrelated to the device.
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Fever
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Blood cultures were negative but patient was hospitalized for antibiotic administration. Patient recovered and event judged to unrelated to the device.
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Fever and hypotension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Required inpatient hospitalization and antibiotics. Patient recovered. Unrelated to the device.
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Pneumonia/Sepsis
time Frame
During stem cell collection (3-6 hours) and following reinfusion of collected stem cell product until neutrophil recovery (1-28 days).

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Preserved source evidence · Not medical advice