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NCT00322387 · ADVERSE EVENTS

Adverse events

Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients · 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
Treatment Period includes the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This period includes G-CSF administration, the plerixafor dose, 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 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 (NHL): Plerixafor PM

Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.

1 / 77 / 7Not reported / Not reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM

Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

0 / 66 / 6Not reported / Not reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo

Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

0 / 11 / 1Not reported / Not reported
Multiple Myeloma (MM): Plerixafor PM

Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.

2 / 1212 / 12Not reported / Not reported
Multiple Myeloma (MM): Plerixafor AM

Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

2 / 99 / 9Not reported / Not reported
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM

Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.

0 / 11 / 1Not reported / Not reported
Multiple Myeloma (MM): Plerixafor After Chemo

Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

1 / 42 / 4Not reported / Not reported

Group identifiers: EG000: Non-Hodgkin's Lymphoma (NHL): Plerixafor PM · EG001: Non-Hodgkin's Lymphoma (NHL): Plerixafor AM · EG002: Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo · EG003: Multiple Myeloma (MM): Plerixafor PM · EG004: Multiple Myeloma (MM): Plerixafor AM · EG005: Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM · EG006: Multiple Myeloma (MM): Plerixafor After Chemo

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
    Five participants experienced neutropenia starting before the first dose of plerixafor.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One participant experienced stapylococcal sepsis immediately after salvage chemotherapy 24 days after the participant received plerixafor.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Staphylococcal sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Cystitis haemorrhagic

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 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Tinnitus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Eyelid oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain lower
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Anal fistula
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Diarrhoea
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 events, regardless of reported relationship to study treatment or grade.
event Groups
  1. description
    Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Non-Hodgkin's Lymphoma (NHL): Plerixafor PM
  2. description
    Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Non-Hodgkin's Lymphoma (NHL): Plerixafor AM
  3. description
    Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo
  4. description
    Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
    id
    EG003
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    2
    serious Num At Risk
    12
    title
    Multiple Myeloma (MM): Plerixafor PM
  5. description
    Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
    id
    EG004
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    2
    serious Num At Risk
    9
    title
    Multiple Myeloma (MM): Plerixafor AM
  6. description
    Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
    id
    EG005
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM
  7. description
    Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.
    id
    EG006
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Multiple Myeloma (MM): Plerixafor After Chemo
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Tinnitus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Eyelid oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain lower
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Anal fistula
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Five participants experienced neutropenia starting before the first dose of plerixafor.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One participant experienced stapylococcal sepsis immediately after salvage chemotherapy 24 days after the participant received plerixafor.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Staphylococcal sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    term
    Cystitis haemorrhagic
time Frame
Treatment Period includes the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This period includes G-CSF administration, the plerixafor dose, and the rest period.

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