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NCT00396331 · ADVERSE EVENTS

Adverse events

AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts · Source last updated 2014-03-13

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
First day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This timeframe includes G-CSF and plerixafor administration, and the rest period.
Other-event reporting threshold
0%

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Non-Hodgkin's Lymphoma

Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

4 / 6664 / 66Not reported / Not reported
Hodgkin's Disease

Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

0 / 2120 / 21Not reported / Not reported
Multiple Myeloma

Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

1 / 109 / 10Not reported / Not reported
Other Cancers

Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

1 / 33 / 3Not reported / Not reported

Group identifiers: EG000: Non-Hodgkin's Lymphoma · EG001: Hodgkin's Disease · EG002: Multiple Myeloma · EG003: Other Cancers

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
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    term
    Intestinal obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Pancreatitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Catheter site infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Central line infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Pneumonia aspiration

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Lymph node pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Cardiac flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Tinnitus
Complete source fields
description
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
event Groups
  1. description
    Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    EG000
    other Num Affected
    64
    other Num At Risk
    66
    serious Num Affected
    4
    serious Num At Risk
    66
    title
    Non-Hodgkin's Lymphoma
  2. description
    Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    EG001
    other Num Affected
    20
    other Num At Risk
    21
    serious Num Affected
    0
    serious Num At Risk
    21
    title
    Hodgkin's Disease
  3. description
    Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    EG002
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    1
    serious Num At Risk
    10
    title
    Multiple Myeloma
  4. description
    Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Other Cancers
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Lymph node pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Cardiac flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Tinnitus
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    term
    Intestinal obstruction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Pancreatitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Catheter site infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Central line infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    term
    Pneumonia aspiration
time Frame
First day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This timeframe includes G-CSF and plerixafor administration, and the rest period.

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Preserved source evidence · Not medical advice