Trial Outcomes & Findings for Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment (NCT NCT00445302)
NCT ID: NCT00445302
Last Updated: 2014-03-13
Results Overview
Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Pre-dose of plerixafor to 24 hours post-plerixafor
Results posted on
2014-03-13
Participant Flow
Cohort enrollment into the study was staged based on baseline creatinine clearance levels, with moderate renal impairment and control participants enrolled first. Severe renal impairment were enrolled following completion of the moderate renal impairment. Participants with mild renal impairment were enrolled last.
Participant milestones
| Measure |
Normal Renal Function
Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Mild Renal Impairment
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Moderate Renal Impairment
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Severe Renal Impairment
Participants with severe renal impairment (CLcr \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
Baseline characteristics by cohort
| Measure |
Normal Renal Function
n=6 Participants
Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment (CLcr \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 5.50 • n=93 Participants
|
56.2 years
STANDARD_DEVIATION 14.45 • n=4 Participants
|
65.0 years
STANDARD_DEVIATION 5.83 • n=27 Participants
|
55.7 years
STANDARD_DEVIATION 11.98 • n=483 Participants
|
54.7 years
STANDARD_DEVIATION 12.51 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
5 participants
n=483 Participants
|
12 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
African-American
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
1 participants
n=483 Participants
|
8 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
3 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Pre-dose of plerixafor to 24 hours post-plerixaforPopulation: Intent-to-treat population
Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.
Outcome measures
| Measure |
Normal Renal Function
n=6 Participants
Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment (CLcr \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
|---|---|---|---|---|
|
Dose-Normalized Maximum Concentration of Plerixafor (Cmax)
|
0.0452 ng/mL/ug
Standard Deviation 0.0145 • Interval 60.03 to 96.9
|
0.0388 ng/mL/ug
Standard Deviation 0.0095 • Interval 74.13 to 117.02
|
0.0490 ng/mL/ug
Standard Deviation 0.0150 • Interval 69.56 to 109.81
|
0.0475 ng/mL/ug
Standard Deviation 0.0110
|
PRIMARY outcome
Timeframe: Pre-dose of plerixafor to 24 hours post-plerixaforPopulation: Intent-to-treat population
Evaluation of AUC0-24 hour following a single dose of 240 µg/kg plerixafor administered on Day 1. AUC0-24 was normalized by dose.
Outcome measures
| Measure |
Normal Renal Function
n=6 Participants
Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment (CLcr \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
|---|---|---|---|---|
|
Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h)
|
0.2277 hr*ng/mL/ug
Standard Deviation 0.0360
|
0.2866 hr*ng/mL/ug
Standard Deviation 0.0854
|
0.3550 hr*ng/mL/ug
Standard Deviation 0.0965
|
0.3872 hr*ng/mL/ug
Standard Deviation 0.0688
|
SECONDARY outcome
Timeframe: Baseline, Day 2Population: An intent-to-treat approach was used to calculate the outcome measure in each arm/group.
Change in circulating CD34+ cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = CD34+ cell count at 24 hours post dose - CD34+ cell count at Baseline.
Outcome measures
| Measure |
Normal Renal Function
n=6 Participants
Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment (CLcr \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
|---|---|---|---|---|
|
Change From Baseline in Absolute CD34+ Cell Counts at Day 2
|
10.5 cells/mm^3
Standard Deviation 6.19
|
11.8 cells/mm^3
Standard Deviation 2.49
|
14.3 cells/mm^3
Standard Deviation 14.24
|
23.0 cells/mm^3
Standard Deviation 18.20
|
SECONDARY outcome
Timeframe: Baseline and Day 2Population: An intent-to-treat approach was used to calculate the outcome measure in each arm/group.
Change in absolute white blood cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = absolute white blood cells at 24 hours post dose - absolute white blood cells at Baseline.
Outcome measures
| Measure |
Normal Renal Function
n=6 Participants
Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment (CLcr \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
|---|---|---|---|---|
|
Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2
|
7416.7 cells/mm^3
Standard Deviation 1986.37
|
10540.0 cells/mm^3
Standard Deviation 2785.32
|
12133.3 cells/mm^3
Standard Deviation 4501.41
|
14975.0 cells/mm^3
Standard Deviation 5030.82
|
SECONDARY outcome
Timeframe: up to Day 3Population: The safety analyses were performed on the Safety Population which consisted of all subjects who received plerixafor.
Number of participants with adverse events (AEs) collected from Day 1 (post plerixafor administration) to Day 3. 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').
Outcome measures
| Measure |
Normal Renal Function
n=6 Participants
Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment (CLcr \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
|---|---|---|---|---|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Severity (Mild)
|
3 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Severity (Moderate)
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Severity (Severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Severity (Life Threatening)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Relationship to Drug (Definitely related)
|
4 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Relationship to Drug (Probably related)
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Relationship to Drug (Possibly related)
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Relationship to Drug (Probably not related)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in Overall Safety Summary of Adverse Events (TEAE)
AE Relationship to Drug (Definitely not related)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Normal Renal Function
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Mild Renal Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Moderate Renal Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Severe Renal Impairment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Renal Function
n=6 participants at risk
Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Mild Renal Impairment
n=6 participants at risk
Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Moderate Renal Impairment
n=5 participants at risk
Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
Severe Renal Impairment
n=6 participants at risk
Participants with severe renal impairment (CLcr \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
General disorders
Feeling hot
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
40.0%
2/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
33.3%
2/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
33.3%
2/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
33.3%
2/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
General disorders
Injection site rash
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
General disorders
Injection site reaction
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Investigations
Red blood cells urine positive
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Investigations
Urinary sediment present
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Investigations
Urine analysis abnormal
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Investigations
White blood cells urine positive
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
33.3%
2/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Nervous system disorders
Paraesthesia
|
33.3%
2/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
33.3%
2/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
20.0%
1/5 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
0.00%
0/6 • From the time of the first dose of plerixafor to study Day 3 (study completion).
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.
|
Additional Information
Genzyme Medical Information
Genzyme Corporation
Phone: 1-800-745-4447
Results disclosure agreements
- Principal investigator is a sponsor employee In multi-site studies, PI can publish after Genzyme publishes or 12 months after study completion. PI gives Genzyme a draft 30 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 90 days upon notifying PI that it will file a patent application on inventions contained in the draft.
- Publication restrictions are in place
Restriction type: OTHER