TriangleNCT00396331 · OUTCOME
Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period
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
What was measured
Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Analysis population: Safety population of all participants who received at least 1 dose of plerixafor.
Groups in this outcome
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.
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.
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.
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.
All Patients
Not reported
| Group | Source count |
|---|---|
| Non-Hodgkin's Lymphoma | 66 |
| Hodgkin's Disease | 21 |
| Multiple Myeloma | 10 |
| Other Cancers | 3 |
| All Patients | 100 |
Reported measurements
Participants Reporting At Least 1 AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 65 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 20 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 9 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 3 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 97 | Not reported | Not reported | Not reported | Not reported |
Adverse Events by Severity -Mild
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 42 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 12 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 7 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 1 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 62 | Not reported | Not reported | Not reported | Not reported |
Adverse Events by Severity -Moderate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 18 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 8 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 1 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 0 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 27 | Not reported | Not reported | Not reported | Not reported |
Adverse Events by Severity -Severe
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 5 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 1 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 2 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 8 | Not reported | Not reported | Not reported | Not reported |
Adverse Events by Severity -Life Threatening
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 0 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 0 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 0 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 0 | Not reported | Not reported | Not reported | Not reported |
AE Relationship to Study Drug -Not Related
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 10 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 4 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 4 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 0 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 18 | Not reported | Not reported | Not reported | Not reported |
AE Relationship to Study Drug-Probably Not Related
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 8 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 2 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 1 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 0 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 11 | Not reported | Not reported | Not reported | Not reported |
AE Relationship to Study Drug -Possibly Related
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 16 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 4 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 1 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 0 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 21 | Not reported | Not reported | Not reported | Not reported |
AE Relationship to Study Drug -Probably Related
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 22 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 2 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 2 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 1 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 27 | Not reported | Not reported | Not reported | Not reported |
AE Relationship to Study Drug -Definitely Related
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | 9 | Not reported | Not reported | Not reported | Not reported |
| Hodgkin's Disease | 8 | Not reported | Not reported | Not reported | Not reported |
| Multiple Myeloma | 1 | Not reported | Not reported | Not reported | Not reported |
| Other Cancers | 2 | Not reported | Not reported | Not reported | Not reported |
| All Patients | 20 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 97
- title
- Participants Reporting At Least 1 AE
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 62
- title
- Adverse Events by Severity -Mild
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 27
- title
- Adverse Events by Severity -Moderate
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 8
- title
- Adverse Events by Severity -Severe
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Adverse Events by Severity -Life Threatening
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 18
- title
- AE Relationship to Study Drug -Not Related
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 11
- title
- AE Relationship to Study Drug-Probably Not Related
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 21
- title
- AE Relationship to Study Drug -Possibly Related
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 27
- title
- AE Relationship to Study Drug -Probably Related
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 20
- title
- AE Relationship to Study Drug -Definitely Related
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 100
- units
- Participants
- description
- Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
- groups
- 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
- OG000
- title
- Non-Hodgkin's Lymphoma
- 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
- OG001
- title
- Hodgkin's Disease
- 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
- OG002
- title
- Multiple Myeloma
- 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
- OG003
- title
- Other Cancers
- id
- OG004
- title
- All Patients
- param Type
- NUMBER
- population Description
- Safety population of all participants who received at least 1 dose of plerixafor.
- reporting Status
- POSTED
- time Frame
- Day 1 to approximately day 38
- title
- Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice