Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01110135 · ADVERSE EVENTS

Adverse events

Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma · Source last updated 2017-05-24

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Chemotherapy and Colony-stimulating Factor)

Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV

6 / 3434 / 34Not reported / Not reported

Group identifiers: EG000: Treatment (Chemotherapy and Colony-stimulating Factor)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Hypotension
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Stroke
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Renal insufficiency
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Atrial fibrillation
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Neutropenic fever
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    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. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      34
    term
    Lymphopenia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      34
    term
    Thrombocytopenia
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      34
    term
    Neutropenia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      34
    term
    Leukopenia
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Hypophosphatemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Hyperglycemia
  7. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Muscle weakness
  8. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Hypotension
Complete source fields
event Groups
  1. description
    Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    6
    serious Num At Risk
    34
    title
    Treatment (Chemotherapy and Colony-stimulating Factor)
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      34
    term
    Lymphopenia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      34
    term
    Thrombocytopenia
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      34
    term
    Neutropenia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      34
    term
    Leukopenia
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Hypophosphatemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Hyperglycemia
  7. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Muscle weakness
  8. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Hypotension
serious Events
  1. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Hypotension
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Stroke
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Renal insufficiency
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Atrial fibrillation
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Neutropenic fever
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Sepsis

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

Preserved source evidence · Not medical advice