Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00103610 · ADVERSE EVENTS

Adverse events

Mobilization of Stem Cells With AMD3100 (Plerixafor) in 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 emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).
Other-event reporting threshold
0%

Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE 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
G-CSF Plus Plerixafor

Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

8 / 150145 / 150Not reported / Not reported
G-CSF Plus Placebo

Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

10 / 145136 / 145Not reported / Not reported

Group identifiers: EG000: G-CSF Plus Plerixafor · EG001: G-CSF Plus Placebo

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      145
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Abdominal pain lower
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Bacteraemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Bacterial sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Catheter bacteraemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Pseudomonal sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Back pain

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
      3
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      145
    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
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      145
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      145
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Extrasystoles
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      145
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      145
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Ventricular extrasystoles
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Ventricular tachyarrhythmia
Complete source fields
description
Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
event Groups
  1. description
    Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
    id
    EG000
    other Num Affected
    145
    other Num At Risk
    150
    serious Num Affected
    8
    serious Num At Risk
    150
    title
    G-CSF Plus Plerixafor
  2. description
    Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
    id
    EG001
    other Num Affected
    136
    other Num At Risk
    145
    serious Num Affected
    10
    serious Num At Risk
    145
    title
    G-CSF Plus Placebo
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
      3
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      145
    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
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      145
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      145
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Extrasystoles
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      145
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      145
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Ventricular extrasystoles
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Ventricular tachyarrhythmia
serious 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
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      145
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Abdominal pain lower
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Bacteraemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Bacterial sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Catheter bacteraemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Pseudomonal sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
    term
    Back pain
time Frame
Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice