NCT00322491 · OUTCOME
Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)
Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma 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.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 to approximately Day 38 (before start of chemotherapy)
What was measured
Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Analysis population: Safety population - all participants who received at least 1 dose of plerixafor.
Groups in this outcome
Non-Hodgkin's Lymphoma (NHL)
Participants with 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 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Multiple Myeloma (MM)
Participants with 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 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
All Participants
Not reported
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 23 |
|---|
| Multiple Myeloma (MM) | 26 |
|---|
| All Participants | 49 |
|---|
Reported measurements
Participants reporting ≥ 1 Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
AE Severity (Mild)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
AE Severity (Moderate)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
AE Severity (Severe)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
AE Relationship to Drug (Not Related)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
AE Relationship to Drug (Probably Not Related)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
AE Relationship to Drug (Possibly Related)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
AE Relationship to Drug (Probably Related)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
AE Relationship to Drug (Definitely Related)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Non-Hodgkin's Lymphoma (NHL) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Multiple Myeloma (MM) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Participants | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 49
- title
- Participants reporting ≥ 1 Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 17
- title
- AE Severity (Mild)
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 7
- title
- AE Severity (Moderate)
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 25
- title
- AE Severity (Severe)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- title
- AE Relationship to Drug (Not Related)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- title
- AE Relationship to Drug (Probably Not Related)
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 17
- title
- AE Relationship to Drug (Possibly Related)
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 19
- title
- AE Relationship to Drug (Probably Related)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- title
- AE Relationship to Drug (Definitely Related)
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 49
- units
- Participants
- description
- Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
- groups
- description
- Participants with 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 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
- id
- OG000
- title
- Non-Hodgkin's Lymphoma (NHL)
- description
- Participants with 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 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
- id
- OG001
- title
- Multiple Myeloma (MM)
- id
- OG002
- title
- All Participants
- param Type
- NUMBER
- population Description
- Safety population - all participants who received at least 1 dose of plerixafor.
- reporting Status
- POSTED
- time Frame
- Day 1 to approximately Day 38 (before start of chemotherapy)
- title
- Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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