Trial Outcomes & Findings for Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy (NCT NCT01003691)
NCT ID: NCT01003691
Last Updated: 2022-05-12
Results Overview
The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade \>= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included serious adverse event (SAE), Grade \>= 3 (increased liver transaminases, encephalopathy/leukoencephalopathy, diarrhea, enteritis or nausea, prolongation of QT interval \[Fridericia's correction\]), Grade \>=2 (central nervous system hemorrhage, decreased total leukocyte count, increased serum creatinine) and thrombocytopenia \<100\*10 9 /liter.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Baseline up to Day 304/End of Treatment (ET)
Results posted on
2022-05-12
Participant Flow
Participant milestones
| Measure |
RN6G 5 mg/kg
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
RN6G 5 mg/kg
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
Baseline characteristics by cohort
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Customized
Greater than or equal to (>=) 75 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Customized
60 to less than (<) 75 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 304/End of Treatment (ET)Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade \>= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included serious adverse event (SAE), Grade \>= 3 (increased liver transaminases, encephalopathy/leukoencephalopathy, diarrhea, enteritis or nausea, prolongation of QT interval \[Fridericia's correction\]), Grade \>=2 (central nervous system hemorrhage, decreased total leukocyte count, increased serum creatinine) and thrombocytopenia \<100\*10 9 /liter.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Number of Participants With Toxicity or Intolerable Dose Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 304/ETPopulation: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. AE was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 2
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 1
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 304/ETPopulation: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
All causalities AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship. Drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. All causalities and drug-related AEs reported wherein drug-related AEs were reported as ocular and non-ocular AEs. Ocular AEs were events which were localized in the ocular region and non-ocular AEs were systemic events which were not localized but occurred throughout the systemic circulation.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug
All causalities AE
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug
Drug-related Ocular AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug
Drug-related non-ocular AE
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 304/ETPopulation: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AE were events which were localized in the ocular region and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 1
|
4 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 2
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 304/ETPopulation: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were events which were localized in the ocular region. Ocular AEs reported as related and non-related to study drug.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
Not Related
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
Related
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 304/ETPopulation: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic AE were events which were not localized but occurred throughout the systemic circulation and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 1
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 2
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 304/ETPopulation: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic TEAEs were events which were not localized but occurred throughout the systemic circulation and reported as related and non-related to study drug.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
Related
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
Not related
|
4 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 304/ETPopulation: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for specified category. Data for Nab was not estimable as no participant was eligible for neutralizing antibody assessment, as there were no positive ADA samples.
The immunogenicity of RN6G (PF-04382923) in terms of producing an antidrug antibody (ADA) and neutralizing antibody response were assessed. Neutralizing antibody response were to be assess in participants with positive ADA samples.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab)
Positive ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672 hours on Day 140Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluated for specified category.
Area under the concentration-time profile from time zero to time tau (Ï„), the dosing interval, where tau = 672 hours.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923)
Day 1
|
NA Microgram*hour per milliliter (mcg*h/mL)
Geometric Coefficient of Variation NA
Data for geometric mean and geometric CV not estimable as only 2 participants were evaluated, individual values were 18800 and 21200 mcg\*h/mL
|
—
|
NA Microgram*hour per milliliter (mcg*h/mL)
Geometric Coefficient of Variation NA
Data for geometric mean and geometric CV not estimable as only 2 participants were evaluated, individual values were 73500 and 80000 mcg\*h/mL
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923)
Day 140
|
50230 Microgram*hour per milliliter (mcg*h/mL)
Geometric Coefficient of Variation 20
|
140300 Microgram*hour per milliliter (mcg*h/mL)
Geometric Coefficient of Variation 14
|
213200 Microgram*hour per milliliter (mcg*h/mL)
Geometric Coefficient of Variation 16
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923)
Day 1
|
142.9 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 12
|
283.4 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 18
|
524.1 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 66
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923)
Day 140
|
185.1 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 16
|
439.8 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 15
|
691.7 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 12
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923)
|
38.43 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 40
|
119.7 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 23
|
201.5 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 27
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.
Css is the concentration of the drug at the state when the amount of drug administered is equal to the amount of drug eliminated.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Plasma Concentration (Css) at Steady State of RN6G (PF-04382923)
|
74.75 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
208.7 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 14
|
317.2 Microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 16
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923)
Day 1
|
1.49 Hour
Interval 1.0 to 3.0
|
2.06 Hour
Interval 1.17 to 4.08
|
2.17 Hour
Interval 1.03 to 4.98
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923)
Day 140
|
1.77 Hour
Interval 1.02 to 2.13
|
2.05 Hour
Interval 1.0 to 5.3
|
1.32 Hour
Interval 1.03 to 1.33
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923)
|
79.52 Milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 23
|
88.04 Milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 26
|
78.45 Milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 11
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.
The mean total time drug resides in the body.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Mean Residence Time (MRT) of RN6G (PF-04382923)
|
818.1 Hour
Standard Deviation 182.15
|
1274 Hour
Standard Deviation 352.28
|
1121 Hour
Standard Deviation 135.38
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Systemic Clearance (CL) of RN6G (PF-04382923)
|
0.09954 Milliliter per hour per kilogram
Geometric Coefficient of Variation 20
|
0.07129 Milliliter per hour per kilogram
Geometric Coefficient of Variation 14
|
0.07036 Milliliter per hour per kilogram
Geometric Coefficient of Variation 16
|
—
|
SECONDARY outcome
Timeframe: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=5 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923)
|
25.14 Hour
Standard Deviation 5.0774
|
42.00 Hour
Standard Deviation 6.6321
|
38.10 Hour
Standard Deviation 4.9738
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Amyloid (A) Beta (1-X) is a primary activator of complement in Alzheimer's disease (AD).
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 14
|
25303.0 Picogram per milliliter (pg/ml)
Standard Deviation 4293.92
|
69611.3 Picogram per milliliter (pg/ml)
Standard Deviation 21077.31
|
80138.0 Picogram per milliliter (pg/ml)
Standard Deviation 13795.55
|
-66.2 Picogram per milliliter (pg/ml)
Standard Deviation 103.72
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Baseline
|
371.8 Picogram per milliliter (pg/ml)
Standard Deviation 284.73
|
1596.8 Picogram per milliliter (pg/ml)
Standard Deviation 2794.08
|
200.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
386.5 Picogram per milliliter (pg/ml)
Standard Deviation 174.33
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 1H post-dose Day 1
|
3340.5 Picogram per milliliter (pg/ml)
Standard Deviation 386.71
|
3205.5 Picogram per milliliter (pg/ml)
Standard Deviation 856.06
|
3947.2 Picogram per milliliter (pg/ml)
Standard Deviation 1822.39
|
0.3 Picogram per milliliter (pg/ml)
Standard Deviation 83.39
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 2H post-dose Day 1
|
5118.7 Picogram per milliliter (pg/ml)
Standard Deviation 709.00
|
4821.2 Picogram per milliliter (pg/ml)
Standard Deviation 1114.32
|
5610.8 Picogram per milliliter (pg/ml)
Standard Deviation 2544.70
|
45.3 Picogram per milliliter (pg/ml)
Standard Deviation 125.22
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 4H post-dose Day 1
|
7850.0 Picogram per milliliter (pg/ml)
Standard Deviation 1490.33
|
6992.7 Picogram per milliliter (pg/ml)
Standard Deviation 1716.83
|
7874.3 Picogram per milliliter (pg/ml)
Standard Deviation 2158.56
|
1.7 Picogram per milliliter (pg/ml)
Standard Deviation 225.19
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 2
|
33804.2 Picogram per milliliter (pg/ml)
Standard Deviation 5420.83
|
33566.0 Picogram per milliliter (pg/ml)
Standard Deviation 4698.42
|
37862.0 Picogram per milliliter (pg/ml)
Standard Deviation 1069.86
|
-9.8 Picogram per milliliter (pg/ml)
Standard Deviation 132.42
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 7
|
50329.3 Picogram per milliliter (pg/ml)
Standard Deviation 9389.75
|
88678.7 Picogram per milliliter (pg/ml)
Standard Deviation 22431.39
|
94017.0 Picogram per milliliter (pg/ml)
Standard Deviation 7060.55
|
16.8 Picogram per milliliter (pg/ml)
Standard Deviation 52.82
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 19
|
17782.7 Picogram per milliliter (pg/ml)
Standard Deviation 4264.51
|
54407.7 Picogram per milliliter (pg/ml)
Standard Deviation 15467.03
|
71190.6 Picogram per milliliter (pg/ml)
Standard Deviation 7553.42
|
-62.5 Picogram per milliliter (pg/ml)
Standard Deviation 106.16
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 28
|
8777.5 Picogram per milliliter (pg/ml)
Standard Deviation 1441.65
|
35848.3 Picogram per milliliter (pg/ml)
Standard Deviation 9540.26
|
57701.0 Picogram per milliliter (pg/ml)
Standard Deviation 14705.10
|
-69.7 Picogram per milliliter (pg/ml)
Standard Deviation 239.14
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 45
|
41329.3 Picogram per milliliter (pg/ml)
Standard Deviation 12376.68
|
87735.4 Picogram per milliliter (pg/ml)
Standard Deviation 19304.46
|
110278.0 Picogram per milliliter (pg/ml)
Standard Deviation 20296.92
|
-6.5 Picogram per milliliter (pg/ml)
Standard Deviation 209.72
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 56
|
23723.0 Picogram per milliliter (pg/ml)
Standard Deviation 4080.35
|
70846.5 Picogram per milliliter (pg/ml)
Standard Deviation 24378.68
|
98343.8 Picogram per milliliter (pg/ml)
Standard Deviation 21336.44
|
-36.3 Picogram per milliliter (pg/ml)
Standard Deviation 305.27
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 75
|
42393.7 Picogram per milliliter (pg/ml)
Standard Deviation 7739.27
|
121176.2 Picogram per milliliter (pg/ml)
Standard Deviation 34652.27
|
149272.0 Picogram per milliliter (pg/ml)
Standard Deviation 23898.10
|
205.6 Picogram per milliliter (pg/ml)
Standard Deviation 302.40
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 84
|
29386.3 Picogram per milliliter (pg/ml)
Standard Deviation 3246.30
|
89908.2 Picogram per milliliter (pg/ml)
Standard Deviation 28896.82
|
120091.6 Picogram per milliliter (pg/ml)
Standard Deviation 5895.10
|
122.2 Picogram per milliliter (pg/ml)
Standard Deviation 362.01
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 103
|
50269.8 Picogram per milliliter (pg/ml)
Standard Deviation 7129.73
|
114474.3 Picogram per milliliter (pg/ml)
Standard Deviation 28268.90
|
157448.0 Picogram per milliliter (pg/ml)
Standard Deviation 33235.41
|
116.6 Picogram per milliliter (pg/ml)
Standard Deviation 296.52
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 112
|
34071.5 Picogram per milliliter (pg/ml)
Standard Deviation 4062.24
|
107243.5 Picogram per milliliter (pg/ml)
Standard Deviation 28813.61
|
140917.6 Picogram per milliliter (pg/ml)
Standard Deviation 17498.78
|
214.4 Picogram per milliliter (pg/ml)
Standard Deviation 342.45
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 131
|
62226.8 Picogram per milliliter (pg/ml)
Standard Deviation 17554.96
|
124417.0 Picogram per milliliter (pg/ml)
Standard Deviation 26689.05
|
168767.8 Picogram per milliliter (pg/ml)
Standard Deviation 7272.93
|
-61.6 Picogram per milliliter (pg/ml)
Standard Deviation 131.01
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at pre-dose Day 140
|
46295.7 Picogram per milliliter (pg/ml)
Standard Deviation 7585.69
|
102548.2 Picogram per milliliter (pg/ml)
Standard Deviation 22902.22
|
154350.0 Picogram per milliliter (pg/ml)
Standard Deviation 9459.75
|
-3.4 Picogram per milliliter (pg/ml)
Standard Deviation 92.42
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 1 H post-dose Day 140
|
41991.0 Picogram per milliliter (pg/ml)
Standard Deviation 7209.04
|
98349.2 Picogram per milliliter (pg/ml)
Standard Deviation 20226.44
|
140246.0 Picogram per milliliter (pg/ml)
Standard Deviation 15770.21
|
-25.0 Picogram per milliliter (pg/ml)
Standard Deviation 80.53
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 2 H Post-dose Day 140
|
49017.8 Picogram per milliliter (pg/ml)
Standard Deviation 6793.71
|
102384.7 Picogram per milliliter (pg/ml)
Standard Deviation 17624.73
|
136109.5 Picogram per milliliter (pg/ml)
Standard Deviation 12883.65
|
-137.3 Picogram per milliliter (pg/ml)
Standard Deviation 135.93
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 4 H Post-dose Day 140
|
51102.8 Picogram per milliliter (pg/ml)
Standard Deviation 6552.83
|
101938.3 Picogram per milliliter (pg/ml)
Standard Deviation 21440.86
|
153793.0 Picogram per milliliter (pg/ml)
Standard Deviation 15312.09
|
-144.2 Picogram per milliliter (pg/ml)
Standard Deviation 158.04
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 141
|
27212.1 Picogram per milliliter (pg/ml)
Standard Deviation 12018.62
|
36042.0 Picogram per milliliter (pg/ml)
Standard Deviation 25934.30
|
80464.2 Picogram per milliliter (pg/ml)
Standard Deviation 11546.49
|
-11.0 Picogram per milliliter (pg/ml)
Standard Deviation 30.66
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 154
|
—
|
141033.8 Picogram per milliliter (pg/ml)
Standard Deviation 22685.63
|
190913.6 Picogram per milliliter (pg/ml)
Standard Deviation 29331.01
|
-103.5 Picogram per milliliter (pg/ml)
Standard Deviation 85.83
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 168
|
52558.0 Picogram per milliliter (pg/ml)
Standard Deviation 6374.13
|
103651.8 Picogram per milliliter (pg/ml)
Standard Deviation 27880.97
|
161691.4 Picogram per milliliter (pg/ml)
Standard Deviation 21292.74
|
-64.6 Picogram per milliliter (pg/ml)
Standard Deviation 132.40
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 224
|
20950.3 Picogram per milliliter (pg/ml)
Standard Deviation 6951.30
|
35489.0 Picogram per milliliter (pg/ml)
Standard Deviation 11571.26
|
57692.0 Picogram per milliliter (pg/ml)
Standard Deviation 16310.16
|
-110.3 Picogram per milliliter (pg/ml)
Standard Deviation 138.97
|
|
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at day 304/ET
|
—
|
13550.8 Picogram per milliliter (pg/ml)
Standard Deviation 5901.76
|
12127.2 Picogram per milliliter (pg/ml)
Standard Deviation 3196.16
|
-164.3 Picogram per milliliter (pg/ml)
Standard Deviation 167.57
|
SECONDARY outcome
Timeframe: Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 1 H post-dose Day 1
|
1194.4 Percent change
Standard Deviation 541.02
|
1032.9 Percent change
Standard Deviation 860.01
|
1973.6 Percent change
Standard Deviation 911.19
|
3.8 Percent change
Standard Deviation 21.25
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 2 H post-dose Day 1
|
1835.9 Percent change
Standard Deviation 859.97
|
1682.9 Percent change
Standard Deviation 1332.55
|
2805.4 Percent change
Standard Deviation 1272.35
|
17.7 Percent change
Standard Deviation 37.96
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percentage change at 4 H post-dose Day 1
|
2899.5 Percent change
Standard Deviation 1575.11
|
2044.5 Percent change
Standard Deviation 1595.93
|
3937.1 Percent change
Standard Deviation 1079.28
|
14.5 Percent change
Standard Deviation 61.22
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 2
|
11999.3 Percent change
Standard Deviation 5344.01
|
9771.3 Percent change
Standard Deviation 6115.66
|
18931.0 Percent change
Standard Deviation 534.93
|
4.3 Percent change
Standard Deviation 29.32
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 7
|
17643.7 Percent change
Standard Deviation 7989.43
|
22214.1 Percent change
Standard Deviation 16132.62
|
47008.5 Percent change
Standard Deviation 3530.28
|
3.1 Percent change
Standard Deviation 13.89
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 14
|
8930.3 Percent change
Standard Deviation 3978.36
|
16692.0 Percent change
Standard Deviation 11490.17
|
40069.0 Percent change
Standard Deviation 6897.78
|
-12.4 Percent change
Standard Deviation 20.10
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 19
|
6096.9 Percent change
Standard Deviation 2660.58
|
13136.7 Percent change
Standard Deviation 9098.67
|
35595.3 Percent change
Standard Deviation 3776.71
|
-13.2 Percent change
Standard Deviation 18.08
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 28
|
3168.7 Percent change
Standard Deviation 1297.49
|
8714.5 Percent change
Standard Deviation 5831.88
|
28850.5 Percent change
Standard Deviation 7352.55
|
-3.3 Percent change
Standard Deviation 72.57
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 45
|
14458.4 Percent change
Standard Deviation 7747.84
|
25626.3 Percent change
Standard Deviation 16350.32
|
55139.0 Percent change
Standard Deviation 10148.46
|
19.0 Percent change
Standard Deviation 84.63
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 56
|
8156.5 Percent change
Standard Deviation 3005.78
|
16396.4 Percent change
Standard Deviation 11269.80
|
49171.9 Percent change
Standard Deviation 10668.22
|
20.9 Percent change
Standard Deviation 120.63
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 75
|
14815.6 Percent change
Standard Deviation 6477.51
|
29483.6 Percent change
Standard Deviation 20874.07
|
74636.0 Percent change
Standard Deviation 11949.05
|
72.3 Percent change
Standard Deviation 122.02
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 84
|
10497.3 Percent change
Standard Deviation 4494.06
|
21128.7 Percent change
Standard Deviation 14305.48
|
60045.8 Percent change
Standard Deviation 2947.55
|
51.2 Percent change
Standard Deviation 124.25
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 103
|
17482.8 Percent change
Standard Deviation 6740.53
|
28726.4 Percent change
Standard Deviation 20620.23
|
78724.0 Percent change
Standard Deviation 16617.70
|
48.2 Percent change
Standard Deviation 120.26
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 112
|
12401.6 Percent change
Standard Deviation 5938.63
|
26653.1 Percent change
Standard Deviation 19128.49
|
70458.8 Percent change
Standard Deviation 8749.39
|
75.8 Percent change
Standard Deviation 138.85
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 131
|
20902.9 Percent change
Standard Deviation 8509.92
|
31839.9 Percent change
Standard Deviation 22850.11
|
84383.9 Percent change
Standard Deviation 3636.46
|
-6.5 Percent change
Standard Deviation 28.29
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Pre-dose Day 140
|
16323.4 Percent change
Standard Deviation 6890.74
|
26584.4 Percent change
Standard Deviation 19667.93
|
77175.0 Percent change
Standard Deviation 4729.87
|
6.8 Percent change
Standard Deviation 25.29
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 1 H Post dose Day 140
|
15067.2 Percent change
Standard Deviation 6922.60
|
25462.2 Percent change
Standard Deviation 18562.61
|
70123.0 Percent change
Standard Deviation 7885.10
|
-2.3 Percent change
Standard Deviation 23.04
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 2 H Post dose Day 140
|
17418.4 Percent change
Standard Deviation 7204.24
|
27192.5 Percent change
Standard Deviation 19768.55
|
68054.8 Percent change
Standard Deviation 6441.82
|
-25.9 Percent change
Standard Deviation 21.26
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 4 H Post dose Day 140
|
18171.1 Percent change
Standard Deviation 7481.91
|
26342.6 Percent change
Standard Deviation 19070.40
|
76896.5 Percent change
Standard Deviation 7656.04
|
-29.4 Percent change
Standard Deviation 24.61
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 141
|
27212.1 Percent change
Standard Deviation 12018.62
|
36042.0 Percent change
Standard Deviation 25934.30
|
80464.2 Percent change
Standard Deviation 11546.49
|
-11.0 Percent change
Standard Deviation 30.66
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 154
|
—
|
37731.7 Percent change
Standard Deviation 28276.18
|
95456.8 Percent change
Standard Deviation 14665.51
|
-21.2 Percent change
Standard Deviation 14.56
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 168
|
19415.4 Percent change
Standard Deviation 9203.47
|
26639.1 Percent change
Standard Deviation 19545.03
|
80845.7 Percent change
Standard Deviation 10646.37
|
-10.1 Percent change
Standard Deviation 29.15
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 224
|
7954.0 Percent change
Standard Deviation 5003.96
|
9003.9 Percent change
Standard Deviation 7319.06
|
28846.0 Percent change
Standard Deviation 8155.08
|
-22.2 Percent change
Standard Deviation 27.76
|
|
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 304 / ET
|
—
|
3182.9 Percent change
Standard Deviation 2499.39
|
6063.6 Percent change
Standard Deviation 1598.08
|
-31.6 Percent change
Standard Deviation 27.03
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at day 304/ET
|
—
|
2483.7 Picogram per milliliter (pg/ml)
Standard Deviation 1124.28
|
3340.8 Picogram per milliliter (pg/ml)
Standard Deviation 994.48
|
26.8 Picogram per milliliter (pg/ml)
Standard Deviation 87.01
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Baseline
|
160.4 Picogram per milliliter (pg/ml)
Standard Deviation 36.33
|
199.7 Picogram per milliliter (pg/ml)
Standard Deviation 24.19
|
209.2 Picogram per milliliter (pg/ml)
Standard Deviation 13.26
|
224.3 Picogram per milliliter (pg/ml)
Standard Deviation 61.26
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 1H post-dose Day 1
|
1271.3 Picogram per milliliter (pg/ml)
Standard Deviation 131.35
|
1306.4 Picogram per milliliter (pg/ml)
Standard Deviation 184.77
|
1548.8 Picogram per milliliter (pg/ml)
Standard Deviation 398.99
|
-3.7 Picogram per milliliter (pg/ml)
Standard Deviation 21.10
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 2 H post-dose Day 1
|
1939.6 Picogram per milliliter (pg/ml)
Standard Deviation 185.16
|
2082.4 Picogram per milliliter (pg/ml)
Standard Deviation 457.09
|
2264.8 Picogram per milliliter (pg/ml)
Standard Deviation 438.40
|
-0.7 Picogram per milliliter (pg/ml)
Standard Deviation 27.10
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 4 H post-dose Day 1
|
3159.6 Picogram per milliliter (pg/ml)
Standard Deviation 510.52
|
3290.3 Picogram per milliliter (pg/ml)
Standard Deviation 525.32
|
3202.3 Picogram per milliliter (pg/ml)
Standard Deviation 730.89
|
4.2 Picogram per milliliter (pg/ml)
Standard Deviation 27.80
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 2
|
10071.3 Picogram per milliliter (pg/ml)
Standard Deviation 1097.81
|
10256.8 Picogram per milliliter (pg/ml)
Standard Deviation 1125.20
|
11164.8 Picogram per milliliter (pg/ml)
Standard Deviation 563.89
|
-5.5 Picogram per milliliter (pg/ml)
Standard Deviation 21.94
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 7
|
12089.6 Picogram per milliliter (pg/ml)
Standard Deviation 2224.22
|
18817.0 Picogram per milliliter (pg/ml)
Standard Deviation 4600.38
|
24150.8 Picogram per milliliter (pg/ml)
Standard Deviation 3178.81
|
-2.8 Picogram per milliliter (pg/ml)
Standard Deviation 16.02
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 14
|
6047.9 Picogram per milliliter (pg/ml)
Standard Deviation 751.77
|
16450.3 Picogram per milliliter (pg/ml)
Standard Deviation 4571.75
|
19050.8 Picogram per milliliter (pg/ml)
Standard Deviation 3495.78
|
-6.5 Picogram per milliliter (pg/ml)
Standard Deviation 13.91
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 19
|
4626.3 Picogram per milliliter (pg/ml)
Standard Deviation 506.10
|
12467.0 Picogram per milliliter (pg/ml)
Standard Deviation 3360.84
|
17990.8 Picogram per milliliter (pg/ml)
Standard Deviation 4568.62
|
8.2 Picogram per milliliter (pg/ml)
Standard Deviation 27.46
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 28
|
2809.6 Picogram per milliliter (pg/ml)
Standard Deviation 534.82
|
9117.0 Picogram per milliliter (pg/ml)
Standard Deviation 2492.73
|
15410.8 Picogram per milliliter (pg/ml)
Standard Deviation 3844.36
|
-3.0 Picogram per milliliter (pg/ml)
Standard Deviation 17.44
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 45
|
10302.9 Picogram per milliliter (pg/ml)
Standard Deviation 2886.26
|
18746.0 Picogram per milliliter (pg/ml)
Standard Deviation 4221.27
|
24150.8 Picogram per milliliter (pg/ml)
Standard Deviation 1138.42
|
-7.7 Picogram per milliliter (pg/ml)
Standard Deviation 46.88
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 56
|
6352.9 Picogram per milliliter (pg/ml)
Standard Deviation 513.41
|
14645.3 Picogram per milliliter (pg/ml)
Standard Deviation 5174.94
|
20630.8 Picogram per milliliter (pg/ml)
Standard Deviation 3400.87
|
-16.8 Picogram per milliliter (pg/ml)
Standard Deviation 46.67
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 75
|
10751.3 Picogram per milliliter (pg/ml)
Standard Deviation 796.75
|
24750.3 Picogram per milliliter (pg/ml)
Standard Deviation 5951.71
|
26910.8 Picogram per milliliter (pg/ml)
Standard Deviation 1110.60
|
-33.0 Picogram per milliliter (pg/ml)
Standard Deviation 24.37
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 84
|
7687.9 Picogram per milliliter (pg/ml)
Standard Deviation 915.03
|
20800.3 Picogram per milliliter (pg/ml)
Standard Deviation 6538.53
|
23270.8 Picogram per milliliter (pg/ml)
Standard Deviation 1691.32
|
-15.6 Picogram per milliliter (pg/ml)
Standard Deviation 61.32
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 103
|
12239.6 Picogram per milliliter (pg/ml)
Standard Deviation 1315.07
|
25900.3 Picogram per milliliter (pg/ml)
Standard Deviation 6385.93
|
29170.8 Picogram per milliliter (pg/ml)
Standard Deviation 5936.75
|
-15.6 Picogram per milliliter (pg/ml)
Standard Deviation 36.92
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 112
|
8517.9 Picogram per milliliter (pg/ml)
Standard Deviation 1608.78
|
23517.0 Picogram per milliliter (pg/ml)
Standard Deviation 6359.32
|
28250.8 Picogram per milliliter (pg/ml)
Standard Deviation 2534.65
|
-18.6 Picogram per milliliter (pg/ml)
Standard Deviation 35.53
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 131
|
15272.9 Picogram per milliliter (pg/ml)
Standard Deviation 2939.43
|
26550.3 Picogram per milliliter (pg/ml)
Standard Deviation 5860.63
|
37614.8 Picogram per milliliter (pg/ml)
Standard Deviation 8703.34
|
7.0 Picogram per milliliter (pg/ml)
Standard Deviation 56.04
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at pre-dose Day 140
|
10402.9 Picogram per milliliter (pg/ml)
Standard Deviation 1699.34
|
20192.0 Picogram per milliliter (pg/ml)
Standard Deviation 10768.73
|
33910.8 Picogram per milliliter (pg/ml)
Standard Deviation 4820.26
|
26.8 Picogram per milliliter (pg/ml)
Standard Deviation 102.19
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 1 H post-dose Day 140
|
12626.3 Picogram per milliliter (pg/ml)
Standard Deviation 2294.39
|
25550.3 Picogram per milliliter (pg/ml)
Standard Deviation 6073.42
|
34470.8 Picogram per milliliter (pg/ml)
Standard Deviation 7089.10
|
-9.0 Picogram per milliliter (pg/ml)
Standard Deviation 41.35
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 2 H Post-dose Day 140
|
13922.9 Picogram per milliliter (pg/ml)
Standard Deviation 2470.45
|
26717.0 Picogram per milliliter (pg/ml)
Standard Deviation 5581.26
|
36114.8 Picogram per milliliter (pg/ml)
Standard Deviation 6268.68
|
-31.0 Picogram per milliliter (pg/ml)
Standard Deviation 27.60
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 4 H Post-dose Day 140
|
15889.6 Picogram per milliliter (pg/ml)
Standard Deviation 1923.62
|
25283.7 Picogram per milliliter (pg/ml)
Standard Deviation 5234.95
|
36750.8 Picogram per milliliter (pg/ml)
Standard Deviation 14910.47
|
-27.4 Picogram per milliliter (pg/ml)
Standard Deviation 38.63
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 141
|
20889.6 Picogram per milliliter (pg/ml)
Standard Deviation 2456.19
|
31733.7 Picogram per milliliter (pg/ml)
Standard Deviation 6395.71
|
39990.8 Picogram per milliliter (pg/ml)
Standard Deviation 8261.80
|
-24.2 Picogram per milliliter (pg/ml)
Standard Deviation 40.38
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 154
|
—
|
25050.3 Picogram per milliliter (pg/ml)
Standard Deviation 5480.90
|
47310.8 Picogram per milliliter (pg/ml)
Standard Deviation 2244.59
|
-35.8 Picogram per milliliter (pg/ml)
Standard Deviation 37.98
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 168
|
11557.9 Picogram per milliliter (pg/ml)
Standard Deviation 2152.82
|
21517.0 Picogram per milliliter (pg/ml)
Standard Deviation 5926.14
|
36750.8 Picogram per milliliter (pg/ml)
Standard Deviation 5023.07
|
-20.4 Picogram per milliliter (pg/ml)
Standard Deviation 52.83
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 224
|
3534.6 Picogram per milliliter (pg/ml)
Standard Deviation 1383.04
|
8518.7 Picogram per milliliter (pg/ml)
Standard Deviation 2946.68
|
14190.8 Picogram per milliliter (pg/ml)
Standard Deviation 3337.13
|
15.3 Picogram per milliliter (pg/ml)
Standard Deviation 66.79
|
SECONDARY outcome
Timeframe: Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 1 H post-dose Day 1
|
838.8 percent change
Standard Deviation 262.62
|
660.9 percent change
Standard Deviation 101.20
|
752.8 percent change
Standard Deviation 247.20
|
0.4 percent change
Standard Deviation 9.79
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 2 H post-dose Day 1
|
1283.4 percent change
Standard Deviation 428.98
|
1051.5 percent change
Standard Deviation 230.65
|
1082.6 percent change
Standard Deviation 225.11
|
1.8 percent change
Standard Deviation 12.92
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 4 H post-dose Day 1
|
2129.1 percent change
Standard Deviation 971.74
|
1649.8 percent change
Standard Deviation 190.06
|
1509.3 percent change
Standard Deviation 255.86
|
3.2 percent change
Standard Deviation 12.13
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 2
|
6536.9 percent change
Standard Deviation 1533.60
|
5332.4 percent change
Standard Deviation 437.02
|
5328.4 percent change
Standard Deviation 422.35
|
-0.4 percent change
Standard Deviation 10.07
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 7
|
8153.4 percent change
Standard Deviation 3691.20
|
9483.1 percent change
Standard Deviation 2136.77
|
11658.5 percent change
Standard Deviation 2346.26
|
-1.0 percent change
Standard Deviation 7.54
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 14
|
4001.5 percent change
Standard Deviation 1313.42
|
8124.3 percent change
Standard Deviation 1400.09
|
9132.2 percent change
Standard Deviation 1770.33
|
-2.1 percent change
Standard Deviation 5.38
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 19
|
3048.1 percent change
Standard Deviation 934.03
|
6169.0 percent change
Standard Deviation 996.40
|
8606.3 percent change
Standard Deviation 2099.47
|
6.5 percent change
Standard Deviation 15.76
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 28
|
1836.7 percent change
Standard Deviation 528.74
|
4501.8 percent change
Standard Deviation 758.64
|
7485.9 percent change
Standard Deviation 2422.75
|
-0.7 percent change
Standard Deviation 8.35
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 45
|
6632.8 percent change
Standard Deviation 2095.25
|
9614.6 percent change
Standard Deviation 1371.10
|
11600.4 percent change
Standard Deviation 1173.09
|
1.0 percent change
Standard Deviation 22.07
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 56
|
4104.0 percent change
Standard Deviation 781.38
|
7229.3 percent change
Standard Deviation 1982.40
|
9938.9 percent change
Standard Deviation 2032.57
|
-2.8 percent change
Standard Deviation 23.72
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 75
|
7033.1 percent change
Standard Deviation 1783.12
|
12296.0 percent change
Standard Deviation 1777.75
|
12933.0 percent change
Standard Deviation 1384.70
|
-12.5 percent change
Standard Deviation 9.43
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 84
|
5034.2 percent change
Standard Deviation 1396.44
|
10287.0 percent change
Standard Deviation 2294.92
|
11153.8 percent change
Standard Deviation 978.44
|
-3.5 percent change
Standard Deviation 28.74
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 103
|
8033.3 percent change
Standard Deviation 2202.15
|
12858.0 percent change
Standard Deviation 1914.67
|
14043.1 percent change
Standard Deviation 3217.61
|
-4.5 percent change
Standard Deviation 16.16
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 112
|
5736.6 percent change
Standard Deviation 2367.32
|
11719.8 percent change
Standard Deviation 2354.18
|
13528.7 percent change
Standard Deviation 1209.21
|
-6.4 percent change
Standard Deviation 15.20
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 131
|
9742.8 percent change
Standard Deviation 1628.75
|
13197.8 percent change
Standard Deviation 1567.68
|
17840.0 percent change
Standard Deviation 3578.16
|
4.9 percent change
Standard Deviation 23.25
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Pre-dose Day 140
|
6750.1 percent change
Standard Deviation 1605.57
|
9991.6 percent change
Standard Deviation 4745.47
|
16216.1 percent change
Standard Deviation 2105.17
|
16.6 percent change
Standard Deviation 51.02
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 1 H Post dose Day 140
|
8274.4 percent change
Standard Deviation 2373.14
|
12713.5 percent change
Standard Deviation 2035.10
|
16473.9 percent change
Standard Deviation 3063.74
|
-1.5 percent change
Standard Deviation 18.15
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 2 H Post dose Day 140
|
9035.4 percent change
Standard Deviation 2212.53
|
13326.7 percent change
Standard Deviation 1838.41
|
17173.8 percent change
Standard Deviation 2625.79
|
-11.2 percent change
Standard Deviation 9.09
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 4 H Post dose Day 140
|
10332.3 percent change
Standard Deviation 2454.30
|
12606.4 percent change
Standard Deviation 1626.29
|
17656.9 percent change
Standard Deviation 7083.30
|
-9.6 percent change
Standard Deviation 13.47
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 141
|
13778.6 percent change
Standard Deviation 4413.73
|
15838.7 percent change
Standard Deviation 2208.15
|
19190.4 percent change
Standard Deviation 4117.80
|
-7.8 percent change
Standard Deviation 15.61
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 154
|
—
|
12461.9 percent change
Standard Deviation 1481.16
|
22722.9 percent change
Standard Deviation 2317.53
|
-12.7 percent change
Standard Deviation 13.89
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 168
|
7539.0 percent change
Standard Deviation 2097.66
|
10766.1 percent change
Standard Deviation 2561.52
|
17703.0 percent change
Standard Deviation 3291.42
|
-5.3 percent change
Standard Deviation 22.33
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 224
|
2277.4 percent change
Standard Deviation 870.42
|
4228.9 percent change
Standard Deviation 1141.96
|
6880.8 percent change
Standard Deviation 2087.34
|
14.5 percent change
Standard Deviation 35.70
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 304 / ET
|
—
|
1263.2 percent change
Standard Deviation 640.49
|
1603.7 percent change
Standard Deviation 481.43
|
10.9 percent change
Standard Deviation 32.02
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Baseline
|
34.0 picogram per milliliter (pg/ml)
Standard Deviation 5.61
|
67.3 picogram per milliliter (pg/ml)
Standard Deviation 36.14
|
46.9 picogram per milliliter (pg/ml)
Standard Deviation 8.62
|
61.4 picogram per milliliter (pg/ml)
Standard Deviation 31.71
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 1H post-dose Day 1
|
65.3 picogram per milliliter (pg/ml)
Standard Deviation 15.08
|
72.4 picogram per milliliter (pg/ml)
Standard Deviation 14.51
|
154.9 picogram per milliliter (pg/ml)
Standard Deviation 49.51
|
-7.7 picogram per milliliter (pg/ml)
Standard Deviation 16.71
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 2 H post-dose Day 1
|
84.6 picogram per milliliter (pg/ml)
Standard Deviation 21.50
|
126.8 picogram per milliliter (pg/ml)
Standard Deviation 36.79
|
193.9 picogram per milliliter (pg/ml)
Standard Deviation 65.55
|
-4.0 picogram per milliliter (pg/ml)
Standard Deviation 19.86
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 4 H post-dose Day 1
|
100.0 picogram per milliliter (pg/ml)
Standard Deviation 18.50
|
179.5 picogram per milliliter (pg/ml)
Standard Deviation 34.06
|
262.6 picogram per milliliter (pg/ml)
Standard Deviation 113.24
|
4.0 picogram per milliliter (pg/ml)
Standard Deviation 5.75
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 2
|
88.6 picogram per milliliter (pg/ml)
Standard Deviation 32.58
|
194.8 picogram per milliliter (pg/ml)
Standard Deviation 48.89
|
328.4 picogram per milliliter (pg/ml)
Standard Deviation 99.74
|
-13.3 picogram per milliliter (pg/ml)
Standard Deviation 26.69
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 7
|
42.1 picogram per milliliter (pg/ml)
Standard Deviation 16.79
|
77.4 picogram per milliliter (pg/ml)
Standard Deviation 26.92
|
144.1 picogram per milliliter (pg/ml)
Standard Deviation 35.08
|
3.9 picogram per milliliter (pg/ml)
Standard Deviation 32.00
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 14
|
18.7 picogram per milliliter (pg/ml)
Standard Deviation 9.18
|
42.4 picogram per milliliter (pg/ml)
Standard Deviation 43.12
|
75.9 picogram per milliliter (pg/ml)
Standard Deviation 19.03
|
9.1 picogram per milliliter (pg/ml)
Standard Deviation 22.03
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 19
|
13.9 picogram per milliliter (pg/ml)
Standard Deviation 5.23
|
33.2 picogram per milliliter (pg/ml)
Standard Deviation 34.62
|
71.2 picogram per milliliter (pg/ml)
Standard Deviation 13.06
|
8.4 picogram per milliliter (pg/ml)
Standard Deviation 22.71
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 28
|
4.8 picogram per milliliter (pg/ml)
Standard Deviation 3.31
|
8.4 picogram per milliliter (pg/ml)
Standard Deviation 28.46
|
68.3 picogram per milliliter (pg/ml)
Standard Deviation 29.29
|
-4.3 picogram per milliliter (pg/ml)
Standard Deviation 11.73
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 45
|
31.3 picogram per milliliter (pg/ml)
Standard Deviation 7.24
|
50.9 picogram per milliliter (pg/ml)
Standard Deviation 31.77
|
123.1 picogram per milliliter (pg/ml)
Standard Deviation 23.36
|
-12.6 picogram per milliliter (pg/ml)
Standard Deviation 25.16
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 56
|
18.0 picogram per milliliter (pg/ml)
Standard Deviation 7.94
|
56.6 picogram per milliliter (pg/ml)
Standard Deviation 61.02
|
101.3 picogram per milliliter (pg/ml)
Standard Deviation 25.80
|
-15.9 picogram per milliliter (pg/ml)
Standard Deviation 28.84
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 75
|
28.9 picogram per milliliter (pg/ml)
Standard Deviation 11.25
|
78.0 picogram per milliliter (pg/ml)
Standard Deviation 51.53
|
144.5 picogram per milliliter (pg/ml)
Standard Deviation 29.38
|
-22.3 picogram per milliliter (pg/ml)
Standard Deviation 27.87
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 84
|
25.6 picogram per milliliter (pg/ml)
Standard Deviation 3.60
|
56.3 picogram per milliliter (pg/ml)
Standard Deviation 54.71
|
104.1 picogram per milliliter (pg/ml)
Standard Deviation 21.92
|
-14.7 picogram per milliliter (pg/ml)
Standard Deviation 26.98
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 103
|
41.9 picogram per milliliter (pg/ml)
Standard Deviation 6.37
|
94.4 picogram per milliliter (pg/ml)
Standard Deviation 49.79
|
141.1 picogram per milliliter (pg/ml)
Standard Deviation 47.02
|
-17.8 picogram per milliliter (pg/ml)
Standard Deviation 28.09
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 112
|
26.2 picogram per milliliter (pg/ml)
Standard Deviation 8.53
|
88.2 picogram per milliliter (pg/ml)
Standard Deviation 58.68
|
124.9 picogram per milliliter (pg/ml)
Standard Deviation 39.52
|
-18.8 picogram per milliliter (pg/ml)
Standard Deviation 22.91
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 131
|
56.3 picogram per milliliter (pg/ml)
Standard Deviation 11.71
|
115.0 picogram per milliliter (pg/ml)
Standard Deviation 68.50
|
180.1 picogram per milliliter (pg/ml)
Standard Deviation 18.23
|
-19.9 picogram per milliliter (pg/ml)
Standard Deviation 24.25
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at pre-dose Day 140
|
37.2 picogram per milliliter (pg/ml)
Standard Deviation 8.51
|
80.2 picogram per milliliter (pg/ml)
Standard Deviation 59.94
|
136.3 picogram per milliliter (pg/ml)
Standard Deviation 9.43
|
-10.9 picogram per milliliter (pg/ml)
Standard Deviation 43.12
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 1 H post-dose Day 140
|
87.8 picogram per milliliter (pg/ml)
Standard Deviation 10.70
|
177.5 picogram per milliliter (pg/ml)
Standard Deviation 67.55
|
257.7 picogram per milliliter (pg/ml)
Standard Deviation 63.99
|
-21.7 picogram per milliliter (pg/ml)
Standard Deviation 25.89
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 2 H Post-dose Day 140
|
113.2 picogram per milliliter (pg/ml)
Standard Deviation 19.82
|
209.2 picogram per milliliter (pg/ml)
Standard Deviation 51.64
|
292.9 picogram per milliliter (pg/ml)
Standard Deviation 57.03
|
-28.7 picogram per milliliter (pg/ml)
Standard Deviation 31.64
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at 4 H Post-dose Day 140
|
132.3 picogram per milliliter (pg/ml)
Standard Deviation 12.73
|
243.7 picogram per milliliter (pg/ml)
Standard Deviation 58.08
|
360.9 picogram per milliliter (pg/ml)
Standard Deviation 66.62
|
-10.5 picogram per milliliter (pg/ml)
Standard Deviation 39.49
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 141
|
120.0 picogram per milliliter (pg/ml)
Standard Deviation 15.08
|
280.2 picogram per milliliter (pg/ml)
Standard Deviation 81.80
|
404.7 picogram per milliliter (pg/ml)
Standard Deviation 84.86
|
-26.1 picogram per milliliter (pg/ml)
Standard Deviation 24.22
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 154
|
—
|
113.4 picogram per milliliter (pg/ml)
Standard Deviation 72.67
|
229.5 picogram per milliliter (pg/ml)
Standard Deviation 29.57
|
-29.3 picogram per milliliter (pg/ml)
Standard Deviation 25.98
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 168
|
39.5 picogram per milliliter (pg/ml)
Standard Deviation 4.78
|
72.7 picogram per milliliter (pg/ml)
Standard Deviation 50.70
|
168.9 picogram per milliliter (pg/ml)
Standard Deviation 34.85
|
-21.9 picogram per milliliter (pg/ml)
Standard Deviation 27.63
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at Day 224
|
8.6 picogram per milliliter (pg/ml)
Standard Deviation 9.82
|
-1.8 picogram per milliliter (pg/ml)
Standard Deviation 41.26
|
45.6 picogram per milliliter (pg/ml)
Standard Deviation 14.60
|
-8.5 picogram per milliliter (pg/ml)
Standard Deviation 42.38
|
|
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Change at day 304/ET
|
—
|
-3.6 picogram per milliliter (pg/ml)
Standard Deviation 40.36
|
4.8 picogram per milliliter (pg/ml)
Standard Deviation 5.31
|
-35.9 picogram per milliliter (pg/ml)
Standard Deviation 26.66
|
SECONDARY outcome
Timeframe: Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 84
|
77.0 percent change
Standard Deviation 16.80
|
146.3 percent change
Standard Deviation 146.97
|
224.2 percent change
Standard Deviation 40.97
|
-12.4 percent change
Standard Deviation 34.64
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 4 H post-dose Day 1
|
306.4 percent change
Standard Deviation 111.88
|
341.8 percent change
Standard Deviation 174.55
|
545.8 percent change
Standard Deviation 131.45
|
10.4 percent change
Standard Deviation 12.86
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 28
|
15.9 percent change
Standard Deviation 14.37
|
36.5 percent change
Standard Deviation 57.79
|
157.6 percent change
Standard Deviation 103.15
|
-2.6 percent change
Standard Deviation 18.74
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 45
|
92.5 percent change
Standard Deviation 17.60
|
118.9 percent change
Standard Deviation 116.56
|
267.5 percent change
Standard Deviation 59.75
|
-7.7 percent change
Standard Deviation 30.53
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 1 H Post dose Day 140
|
264.4 percent change
Standard Deviation 55.03
|
345.7 percent change
Standard Deviation 201.63
|
553.7 percent change
Standard Deviation 122.06
|
-24.0 percent change
Standard Deviation 24.14
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 1 H post-dose Day 1
|
199.0 percent change
Standard Deviation 74.28
|
163.7 percent change
Standard Deviation 102.35
|
340.2 percent change
Standard Deviation 133.10
|
-7.0 percent change
Standard Deviation 20.63
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 2 H post-dose Day 1
|
257.8 percent change
Standard Deviation 101.75
|
254.3 percent change
Standard Deviation 104.05
|
412.7 percent change
Standard Deviation 98.90
|
0.5 percent change
Standard Deviation 23.12
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 2
|
278.1 percent change
Standard Deviation 163.60
|
461.6 percent change
Standard Deviation 175.95
|
708.5 percent change
Standard Deviation 200.76
|
-9.8 percent change
Standard Deviation 31.29
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 7
|
129.8 percent change
Standard Deviation 71.07
|
164.3 percent change
Standard Deviation 114.69
|
306.5 percent change
Standard Deviation 45.29
|
19.6 percent change
Standard Deviation 58.46
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 14
|
59.7 percent change
Standard Deviation 38.36
|
121.1 percent change
Standard Deviation 132.70
|
163.7 percent change
Standard Deviation 37.92
|
21.2 percent change
Standard Deviation 47.33
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 19
|
43.0 percent change
Standard Deviation 20.81
|
87.2 percent change
Standard Deviation 92.62
|
153.3 percent change
Standard Deviation 25.60
|
20.9 percent change
Standard Deviation 49.01
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 56
|
55.8 percent change
Standard Deviation 34.06
|
102.2 percent change
Standard Deviation 74.51
|
220.4 percent change
Standard Deviation 62.44
|
-10.7 percent change
Standard Deviation 36.98
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 75
|
87.8 percent change
Standard Deviation 38.89
|
172.1 percent change
Standard Deviation 141.94
|
314.3 percent change
Standard Deviation 75.17
|
-23.6 percent change
Standard Deviation 27.01
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 103
|
128.9 percent change
Standard Deviation 42.92
|
207.3 percent change
Standard Deviation 159.23
|
315.3 percent change
Standard Deviation 127.45
|
-16.7 percent change
Standard Deviation 29.36
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 112
|
83.2 percent change
Standard Deviation 46.16
|
207.4 percent change
Standard Deviation 176.39
|
275.2 percent change
Standard Deviation 92.55
|
-20.2 percent change
Standard Deviation 21.83
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 131
|
168.4 percent change
Standard Deviation 41.44
|
249.0 percent change
Standard Deviation 204.05
|
393.6 percent change
Standard Deviation 66.08
|
-21.1 percent change
Standard Deviation 25.48
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Pre-dose Day 140
|
111.1 percent change
Standard Deviation 25.89
|
185.8 percent change
Standard Deviation 164.10
|
297.3 percent change
Standard Deviation 48.94
|
0.2 percent change
Standard Deviation 68.99
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 2 H Post dose Day 140
|
337.7 percent change
Standard Deviation 67.82
|
394.6 percent change
Standard Deviation 196.64
|
637.8 percent change
Standard Deviation 146.28
|
-28.8 percent change
Standard Deviation 33.79
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at 4 H Post dose Day 140
|
397.0 percent change
Standard Deviation 70.71
|
459.8 percent change
Standard Deviation 234.24
|
781.5 percent change
Standard Deviation 165.36
|
-4.9 percent change
Standard Deviation 53.65
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 141
|
360.6 percent change
Standard Deviation 70.15
|
539.2 percent change
Standard Deviation 291.07
|
889.4 percent change
Standard Deviation 267.61
|
-31.3 percent change
Standard Deviation 20.95
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 154
|
—
|
241.5 percent change
Standard Deviation 196.56
|
506.2 percent change
Standard Deviation 142.03
|
-32.3 percent change
Standard Deviation 22.75
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 168
|
119.7 percent change
Standard Deviation 30.44
|
176.4 percent change
Standard Deviation 159.42
|
366.6 percent change
Standard Deviation 91.33
|
-22.8 percent change
Standard Deviation 27.34
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 224
|
29.7 percent change
Standard Deviation 37.85
|
27.1 percent change
Standard Deviation 74.59
|
102.6 percent change
Standard Deviation 41.52
|
8.2 percent change
Standard Deviation 68.87
|
|
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Percent change at Day 304 / ET
|
—
|
15.4 percent change
Standard Deviation 66.96
|
11.0 percent change
Standard Deviation 12.78
|
-38.8 percent change
Standard Deviation 22.12
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 hour (H) post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ETPopulation: Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4-8 H post-dose day 56: SBP
|
4.8 millimeter of mercury (mmHg)
Standard Deviation 10.82
|
-1.7 millimeter of mercury (mmHg)
Standard Deviation 7.34
|
-0.2 millimeter of mercury (mmHg)
Standard Deviation 11.58
|
8.2 millimeter of mercury (mmHg)
Standard Deviation 17.48
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Baseline: SBP
|
128.0 millimeter of mercury (mmHg)
Standard Deviation 10.58
|
128.7 millimeter of mercury (mmHg)
Standard Deviation 18.05
|
127.3 millimeter of mercury (mmHg)
Standard Deviation 7.37
|
125.3 millimeter of mercury (mmHg)
Standard Deviation 12.19
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 1H post-dose Day 1: SBP
|
11.3 millimeter of mercury (mmHg)
Standard Deviation 10.71
|
-5.7 millimeter of mercury (mmHg)
Standard Deviation 16.56
|
3.8 millimeter of mercury (mmHg)
Standard Deviation 11.70
|
2.5 millimeter of mercury (mmHg)
Standard Deviation 6.38
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4 H post-dose Day 1: SBP
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 8.56
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 17.42
|
2.2 millimeter of mercury (mmHg)
Standard Deviation 9.64
|
2.7 millimeter of mercury (mmHg)
Standard Deviation 12.55
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 24 H post-dose Day 2: SBP
|
5.0 millimeter of mercury (mmHg)
Standard Deviation 11.22
|
-10.7 millimeter of mercury (mmHg)
Standard Deviation 18.53
|
-5.0 millimeter of mercury (mmHg)
Standard Deviation 8.29
|
0.8 millimeter of mercury (mmHg)
Standard Deviation 4.62
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 7: SBP
|
7.3 millimeter of mercury (mmHg)
Standard Deviation 22.08
|
-5.3 millimeter of mercury (mmHg)
Standard Deviation 15.47
|
-1.5 millimeter of mercury (mmHg)
Standard Deviation 7.74
|
-4.0 millimeter of mercury (mmHg)
Standard Deviation 4.15
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 14: SBP
|
2.0 millimeter of mercury (mmHg)
Standard Deviation 15.13
|
-1.5 millimeter of mercury (mmHg)
Standard Deviation 9.29
|
-7.2 millimeter of mercury (mmHg)
Standard Deviation 11.84
|
2.8 millimeter of mercury (mmHg)
Standard Deviation 7.49
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 19: SBP
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 7.45
|
-6.2 millimeter of mercury (mmHg)
Standard Deviation 9.43
|
-8.6 millimeter of mercury (mmHg)
Standard Deviation 8.35
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 3.20
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 28: SBP
|
7.7 millimeter of mercury (mmHg)
Standard Deviation 11.83
|
-8.8 millimeter of mercury (mmHg)
Standard Deviation 10.09
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 11.76
|
-0.3 millimeter of mercury (mmHg)
Standard Deviation 9.56
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4-8 H post-dose Day 28: SBP
|
7.7 millimeter of mercury (mmHg)
Standard Deviation 10.61
|
-5.5 millimeter of mercury (mmHg)
Standard Deviation 12.29
|
3.6 millimeter of mercury (mmHg)
Standard Deviation 11.80
|
7.3 millimeter of mercury (mmHg)
Standard Deviation 18.69
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 45: SBP
|
3.7 millimeter of mercury (mmHg)
Standard Deviation 6.62
|
0.3 millimeter of mercury (mmHg)
Standard Deviation 12.31
|
-1.6 millimeter of mercury (mmHg)
Standard Deviation 23.42
|
4.3 millimeter of mercury (mmHg)
Standard Deviation 7.12
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 56: SBP
|
5.0 millimeter of mercury (mmHg)
Standard Deviation 15.48
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 9.61
|
-4.5 millimeter of mercury (mmHg)
Standard Deviation 14.71
|
3.2 millimeter of mercury (mmHg)
Standard Deviation 9.52
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 75: SBP
|
-0.7 millimeter of mercury (mmHg)
Standard Deviation 19.34
|
-1.8 millimeter of mercury (mmHg)
Standard Deviation 16.57
|
1.8 millimeter of mercury (mmHg)
Standard Deviation 15.88
|
6.0 millimeter of mercury (mmHg)
Standard Deviation 11.77
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Pre-dose Day 84: SBP
|
3.2 millimeter of mercury (mmHg)
Standard Deviation 15.05
|
-0.8 millimeter of mercury (mmHg)
Standard Deviation 8.91
|
-0.3 millimeter of mercury (mmHg)
Standard Deviation 15.88
|
10.0 millimeter of mercury (mmHg)
Standard Deviation 9.67
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4-8H post-dose Day 84: SBP
|
0.0 millimeter of mercury (mmHg)
Standard Deviation 9.63
|
-7.0 millimeter of mercury (mmHg)
Standard Deviation 12.62
|
3.8 millimeter of mercury (mmHg)
Standard Deviation 10.30
|
7.0 millimeter of mercury (mmHg)
Standard Deviation 13.58
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 103: SBP
|
2.0 millimeter of mercury (mmHg)
Standard Deviation 13.08
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 11.29
|
5.5 millimeter of mercury (mmHg)
Standard Deviation 8.62
|
11.4 millimeter of mercury (mmHg)
Standard Deviation 12.03
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 112: SBP
|
-2.0 millimeter of mercury (mmHg)
Standard Deviation 12.65
|
-1.2 millimeter of mercury (mmHg)
Standard Deviation 17.28
|
-0.5 millimeter of mercury (mmHg)
Standard Deviation 10.35
|
12.8 millimeter of mercury (mmHg)
Standard Deviation 8.87
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4-8 H post-dose Day 112: SBP
|
-4.7 millimeter of mercury (mmHg)
Standard Deviation 8.26
|
-2.7 millimeter of mercury (mmHg)
Standard Deviation 10.25
|
-1.7 millimeter of mercury (mmHg)
Standard Deviation 11.64
|
7.4 millimeter of mercury (mmHg)
Standard Deviation 14.62
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 131: SBP
|
4.3 millimeter of mercury (mmHg)
Standard Deviation 13.11
|
0.2 millimeter of mercury (mmHg)
Standard Deviation 12.59
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 9.75
|
12.2 millimeter of mercury (mmHg)
Standard Deviation 13.20
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 140: SBP
|
-5.3 millimeter of mercury (mmHg)
Standard Deviation 15.78
|
-2.3 millimeter of mercury (mmHg)
Standard Deviation 16.42
|
-2.8 millimeter of mercury (mmHg)
Standard Deviation 8.16
|
2.6 millimeter of mercury (mmHg)
Standard Deviation 8.56
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 1 H post-dose Day 140: SBP
|
-0.7 millimeter of mercury (mmHg)
Standard Deviation 11.64
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 12.75
|
-1.0 millimeter of mercury (mmHg)
Standard Deviation 13.71
|
5.4 millimeter of mercury (mmHg)
Standard Deviation 20.51
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4 H post dose Day 140: SBP
|
-6.0 millimeter of mercury (mmHg)
Standard Deviation 9.96
|
-6.7 millimeter of mercury (mmHg)
Standard Deviation 16.44
|
-3.3 millimeter of mercury (mmHg)
Standard Deviation 8.57
|
12.4 millimeter of mercury (mmHg)
Standard Deviation 7.44
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 24 H post dose Day 141: SBP
|
-6.0 millimeter of mercury (mmHg)
Standard Deviation 11.10
|
-2.5 millimeter of mercury (mmHg)
Standard Deviation 10.43
|
-0.7 millimeter of mercury (mmHg)
Standard Deviation 3.33
|
10.2 millimeter of mercury (mmHg)
Standard Deviation 11.99
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 154: SBP
|
—
|
-2.7 millimeter of mercury (mmHg)
Standard Deviation 8.80
|
-6.7 millimeter of mercury (mmHg)
Standard Deviation 8.24
|
0.3 millimeter of mercury (mmHg)
Standard Deviation 7.41
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 168: SBP
|
5.8 millimeter of mercury (mmHg)
Standard Deviation 24.04
|
-0.8 millimeter of mercury (mmHg)
Standard Deviation 11.18
|
-11.8 millimeter of mercury (mmHg)
Standard Deviation 7.96
|
5.2 millimeter of mercury (mmHg)
Standard Deviation 11.12
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 224/ET: SBP
|
1.8 millimeter of mercury (mmHg)
Standard Deviation 15.83
|
4.7 millimeter of mercury (mmHg)
Standard Deviation 14.88
|
-3.0 millimeter of mercury (mmHg)
Standard Deviation 12.81
|
5.5 millimeter of mercury (mmHg)
Standard Deviation 9.93
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 304/ET: SBP
|
—
|
-1.7 millimeter of mercury (mmHg)
Standard Deviation 9.07
|
0.5 millimeter of mercury (mmHg)
Standard Deviation 18.57
|
2.3 millimeter of mercury (mmHg)
Standard Deviation 15.52
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Baseline: DBP
|
78.7 millimeter of mercury (mmHg)
Standard Deviation 7.55
|
75.0 millimeter of mercury (mmHg)
Standard Deviation 10.56
|
80.3 millimeter of mercury (mmHg)
Standard Deviation 7.74
|
76.7 millimeter of mercury (mmHg)
Standard Deviation 5.99
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 1 H post-dose Day 1: DBP
|
-0.3 millimeter of mercury (mmHg)
Standard Deviation 7.09
|
3.5 millimeter of mercury (mmHg)
Standard Deviation 9.38
|
3.0 millimeter of mercury (mmHg)
Standard Deviation 8.44
|
-3.3 millimeter of mercury (mmHg)
Standard Deviation 7.26
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4 H post-dose Day 1: DBP
|
-3.7 millimeter of mercury (mmHg)
Standard Deviation 11.48
|
-1.5 millimeter of mercury (mmHg)
Standard Deviation 8.09
|
0.2 millimeter of mercury (mmHg)
Standard Deviation 8.01
|
-4.3 millimeter of mercury (mmHg)
Standard Deviation 4.03
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 24 H post-dose Day 2: DBP
|
-2.7 millimeter of mercury (mmHg)
Standard Deviation 8.36
|
-0.7 millimeter of mercury (mmHg)
Standard Deviation 5.32
|
-4.7 millimeter of mercury (mmHg)
Standard Deviation 8.80
|
-2.2 millimeter of mercury (mmHg)
Standard Deviation 8.82
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 7: DBP
|
-1.7 millimeter of mercury (mmHg)
Standard Deviation 11.48
|
4.7 millimeter of mercury (mmHg)
Standard Deviation 8.26
|
-2.7 millimeter of mercury (mmHg)
Standard Deviation 9.44
|
-2.3 millimeter of mercury (mmHg)
Standard Deviation 6.47
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 14: DBP
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 6.02
|
3.7 millimeter of mercury (mmHg)
Standard Deviation 9.91
|
-3.7 millimeter of mercury (mmHg)
Standard Deviation 10.63
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 6.06
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 19: DBP
|
-1.7 millimeter of mercury (mmHg)
Standard Deviation 7.84
|
-1.2 millimeter of mercury (mmHg)
Standard Deviation 6.59
|
-5.4 millimeter of mercury (mmHg)
Standard Deviation 4.45
|
-3.7 millimeter of mercury (mmHg)
Standard Deviation 6.83
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 28: DBP
|
-1.0 millimeter of mercury (mmHg)
Standard Deviation 11.51
|
-2.2 millimeter of mercury (mmHg)
Standard Deviation 8.95
|
-2.8 millimeter of mercury (mmHg)
Standard Deviation 11.72
|
-4.8 millimeter of mercury (mmHg)
Standard Deviation 8.16
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4-8 H post-dose Day 28:DBP
|
0.7 millimeter of mercury (mmHg)
Standard Deviation 6.53
|
0.0 millimeter of mercury (mmHg)
Standard Deviation 12.90
|
2.6 millimeter of mercury (mmHg)
Standard Deviation 4.22
|
-4.5 millimeter of mercury (mmHg)
Standard Deviation 7.15
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 45: DBP
|
1.7 millimeter of mercury (mmHg)
Standard Deviation 5.99
|
5.8 millimeter of mercury (mmHg)
Standard Deviation 11.74
|
-4.6 millimeter of mercury (mmHg)
Standard Deviation 11.99
|
-2.0 millimeter of mercury (mmHg)
Standard Deviation 10.97
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 56: DBP
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 5.33
|
0.3 millimeter of mercury (mmHg)
Standard Deviation 10.98
|
-1.0 millimeter of mercury (mmHg)
Standard Deviation 5.06
|
2.3 millimeter of mercury (mmHg)
Standard Deviation 8.73
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4-8 H post-dose day 56: DBP
|
0.8 millimeter of mercury (mmHg)
Standard Deviation 5.00
|
-0.5 millimeter of mercury (mmHg)
Standard Deviation 11.93
|
1.4 millimeter of mercury (mmHg)
Standard Deviation 7.20
|
-3.0 millimeter of mercury (mmHg)
Standard Deviation 6.44
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 75: DBP
|
-0.3 millimeter of mercury (mmHg)
Standard Deviation 6.12
|
-3.2 millimeter of mercury (mmHg)
Standard Deviation 10.01
|
-4.6 millimeter of mercury (mmHg)
Standard Deviation 5.59
|
-1.2 millimeter of mercury (mmHg)
Standard Deviation 6.53
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 84: DBP
|
-0.7 millimeter of mercury (mmHg)
Standard Deviation 8.45
|
0.8 millimeter of mercury (mmHg)
Standard Deviation 14.76
|
-1.2 millimeter of mercury (mmHg)
Standard Deviation 11.39
|
2.2 millimeter of mercury (mmHg)
Standard Deviation 7.66
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4-8 H post-dose Day 84:DBP
|
-6.7 millimeter of mercury (mmHg)
Standard Deviation 7.97
|
-3.0 millimeter of mercury (mmHg)
Standard Deviation 8.07
|
0.5 millimeter of mercury (mmHg)
Standard Deviation 10.25
|
-2.0 millimeter of mercury (mmHg)
Standard Deviation 6.67
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 103: DBP
|
-5.0 millimeter of mercury (mmHg)
Standard Deviation 5.76
|
0.3 millimeter of mercury (mmHg)
Standard Deviation 12.23
|
2.2 millimeter of mercury (mmHg)
Standard Deviation 7.96
|
3.4 millimeter of mercury (mmHg)
Standard Deviation 4.04
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 112: DBP
|
-1.8 millimeter of mercury (mmHg)
Standard Deviation 8.35
|
3.3 millimeter of mercury (mmHg)
Standard Deviation 10.80
|
-2.3 millimeter of mercury (mmHg)
Standard Deviation 5.01
|
4.4 millimeter of mercury (mmHg)
Standard Deviation 4.39
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4-8 H post-dose Day 112:DBP
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 8.16
|
0.0 millimeter of mercury (mmHg)
Standard Deviation 10.73
|
-1.0 millimeter of mercury (mmHg)
Standard Deviation 6.93
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 7.55
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 131: DBP
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 3.01
|
-1.7 millimeter of mercury (mmHg)
Standard Deviation 8.48
|
-3.4 millimeter of mercury (mmHg)
Standard Deviation 8.99
|
0.0 millimeter of mercury (mmHg)
Standard Deviation 5.34
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at pre-dose Day 140: DBP
|
-4.3 millimeter of mercury (mmHg)
Standard Deviation 10.15
|
2.5 millimeter of mercury (mmHg)
Standard Deviation 11.20
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 14.52
|
-0.4 millimeter of mercury (mmHg)
Standard Deviation 5.32
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 1 H post-dose Day 140: DBP
|
-2.7 millimeter of mercury (mmHg)
Standard Deviation 7.87
|
4.2 millimeter of mercury (mmHg)
Standard Deviation 10.82
|
-1.3 millimeter of mercury (mmHg)
Standard Deviation 10.19
|
-2.2 millimeter of mercury (mmHg)
Standard Deviation 6.22
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 4 H post dose Day 140: DBP
|
-6.3 millimeter of mercury (mmHg)
Standard Deviation 8.24
|
3.3 millimeter of mercury (mmHg)
Standard Deviation 9.20
|
-6.5 millimeter of mercury (mmHg)
Standard Deviation 8.24
|
-2.2 millimeter of mercury (mmHg)
Standard Deviation 5.22
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at 24 H post dose Day 141: DBP
|
-4.7 millimeter of mercury (mmHg)
Standard Deviation 4.13
|
2.2 millimeter of mercury (mmHg)
Standard Deviation 12.04
|
-4.5 millimeter of mercury (mmHg)
Standard Deviation 7.09
|
0.6 millimeter of mercury (mmHg)
Standard Deviation 6.73
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 154: DBP
|
—
|
2.5 millimeter of mercury (mmHg)
Standard Deviation 8.85
|
-5.5 millimeter of mercury (mmHg)
Standard Deviation 5.79
|
-4.0 millimeter of mercury (mmHg)
Standard Deviation 4.97
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 168: DBP
|
-2.2 millimeter of mercury (mmHg)
Standard Deviation 6.88
|
0.0 millimeter of mercury (mmHg)
Standard Deviation 11.51
|
-4.8 millimeter of mercury (mmHg)
Standard Deviation 7.00
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 5.92
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 224/ET: DBP
|
-0.8 millimeter of mercury (mmHg)
Standard Deviation 8.50
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 8.00
|
-3.0 millimeter of mercury (mmHg)
Standard Deviation 4.52
|
-0.5 millimeter of mercury (mmHg)
Standard Deviation 5.96
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Change at Day 304/ET: DBP
|
—
|
1.3 millimeter of mercury (mmHg)
Standard Deviation 11.57
|
1.2 millimeter of mercury (mmHg)
Standard Deviation 16.41
|
2.8 millimeter of mercury (mmHg)
Standard Deviation 4.99
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ETPopulation: Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Baseline
|
64.2 Beats per minute
Standard Deviation 6.40
|
62.8 Beats per minute
Standard Deviation 4.40
|
66.5 Beats per minute
Standard Deviation 6.53
|
66.7 Beats per minute
Standard Deviation 5.01
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 1H post-dose Day 1
|
1.7 Beats per minute
Standard Deviation 2.66
|
-1.8 Beats per minute
Standard Deviation 4.40
|
-4.2 Beats per minute
Standard Deviation 5.46
|
1.0 Beats per minute
Standard Deviation 8.83
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 4 H post-dose Day 1
|
3.5 Beats per minute
Standard Deviation 6.25
|
1.2 Beats per minute
Standard Deviation 5.81
|
-2.3 Beats per minute
Standard Deviation 7.50
|
4.0 Beats per minute
Standard Deviation 7.77
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 24 H post-dose Day 2
|
0.8 Beats per minute
Standard Deviation 2.71
|
1.5 Beats per minute
Standard Deviation 1.97
|
-2.0 Beats per minute
Standard Deviation 3.74
|
3.8 Beats per minute
Standard Deviation 6.40
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 7
|
4.5 Beats per minute
Standard Deviation 3.67
|
3.3 Beats per minute
Standard Deviation 3.08
|
-4.2 Beats per minute
Standard Deviation 5.42
|
4.2 Beats per minute
Standard Deviation 5.95
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 14
|
1.2 Beats per minute
Standard Deviation 2.04
|
4.3 Beats per minute
Standard Deviation 7.39
|
0.3 Beats per minute
Standard Deviation 4.59
|
6.0 Beats per minute
Standard Deviation 6.93
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 19
|
2.5 Beats per minute
Standard Deviation 5.92
|
7.8 Beats per minute
Standard Deviation 7.60
|
0.0 Beats per minute
Standard Deviation 2.45
|
1.0 Beats per minute
Standard Deviation 5.76
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at pre-dose Day 28
|
0.2 Beats per minute
Standard Deviation 5.53
|
2.3 Beats per minute
Standard Deviation 5.32
|
-1.5 Beats per minute
Standard Deviation 5.72
|
-1.2 Beats per minute
Standard Deviation 2.71
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 4-8 H post-dose Day 28
|
6.5 Beats per minute
Standard Deviation 10.15
|
2.2 Beats per minute
Standard Deviation 2.56
|
-2.8 Beats per minute
Standard Deviation 4.32
|
0.3 Beats per minute
Standard Deviation 12.04
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 45
|
3.5 Beats per minute
Standard Deviation 2.17
|
2.3 Beats per minute
Standard Deviation 4.03
|
5.2 Beats per minute
Standard Deviation 7.26
|
-3.0 Beats per minute
Standard Deviation 5.73
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at pre-dose Day 56
|
1.2 Beats per minute
Standard Deviation 2.99
|
1.5 Beats per minute
Standard Deviation 4.37
|
-3.7 Beats per minute
Standard Deviation 5.13
|
2.0 Beats per minute
Standard Deviation 5.51
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 4-8 H post-dose day 56
|
3.0 Beats per minute
Standard Deviation 4.69
|
2.3 Beats per minute
Standard Deviation 4.13
|
1.6 Beats per minute
Standard Deviation 10.14
|
6.0 Beats per minute
Standard Deviation 9.08
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 75
|
1.5 Beats per minute
Standard Deviation 4.64
|
5.5 Beats per minute
Standard Deviation 6.19
|
8.0 Beats per minute
Standard Deviation 8.12
|
6.8 Beats per minute
Standard Deviation 8.90
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at pre-dose Day 84
|
2.3 Beats per minute
Standard Deviation 3.83
|
4.0 Beats per minute
Standard Deviation 3.10
|
-1.8 Beats per minute
Standard Deviation 4.17
|
2.2 Beats per minute
Standard Deviation 7.09
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 4-8 H post-dose Day 84
|
-0.3 Beats per minute
Standard Deviation 5.89
|
1.8 Beats per minute
Standard Deviation 4.31
|
-2.7 Beats per minute
Standard Deviation 7.76
|
4.2 Beats per minute
Standard Deviation 5.12
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 103
|
2.2 Beats per minute
Standard Deviation 2.04
|
2.5 Beats per minute
Standard Deviation 4.09
|
1.3 Beats per minute
Standard Deviation 1.63
|
6.0 Beats per minute
Standard Deviation 5.29
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at pre-dose Day 112
|
-0.8 Beats per minute
Standard Deviation 4.02
|
1.5 Beats per minute
Standard Deviation 3.33
|
-0.2 Beats per minute
Standard Deviation 4.26
|
0.2 Beats per minute
Standard Deviation 5.02
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 4-8 H post-dose Day 112
|
1.8 Beats per minute
Standard Deviation 2.86
|
3.3 Beats per minute
Standard Deviation 5.05
|
-2.2 Beats per minute
Standard Deviation 3.19
|
-1.6 Beats per minute
Standard Deviation 0.89
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 131
|
1.8 Beats per minute
Standard Deviation 4.07
|
7.2 Beats per minute
Standard Deviation 7.55
|
2.8 Beats per minute
Standard Deviation 13.07
|
1.8 Beats per minute
Standard Deviation 6.94
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at pre-dose Day 140
|
2.5 Beats per minute
Standard Deviation 3.99
|
2.8 Beats per minute
Standard Deviation 4.07
|
-0.8 Beats per minute
Standard Deviation 4.79
|
3.2 Beats per minute
Standard Deviation 3.27
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 1 H post-dose Day 140
|
-0.5 Beats per minute
Standard Deviation 4.37
|
0.8 Beats per minute
Standard Deviation 5.53
|
-4.5 Beats per minute
Standard Deviation 6.83
|
-3.2 Beats per minute
Standard Deviation 9.09
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 4 H post dose Day 140.
|
3.2 Beats per minute
Standard Deviation 4.83
|
4.0 Beats per minute
Standard Deviation 8.94
|
-2.8 Beats per minute
Standard Deviation 6.91
|
-1.0 Beats per minute
Standard Deviation 10.20
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at 24 H post dose Day 141
|
1.0 Beats per minute
Standard Deviation 3.22
|
8.7 Beats per minute
Standard Deviation 3.88
|
-2.0 Beats per minute
Standard Deviation 6.10
|
6.4 Beats per minute
Standard Deviation 4.77
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 154
|
—
|
9.2 Beats per minute
Standard Deviation 3.82
|
0.5 Beats per minute
Standard Deviation 8.73
|
13.5 Beats per minute
Standard Deviation 5.00
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 168
|
1.7 Beats per minute
Standard Deviation 1.86
|
-0.5 Beats per minute
Standard Deviation 4.89
|
-6.8 Beats per minute
Standard Deviation 5.42
|
4.8 Beats per minute
Standard Deviation 7.56
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 224/ET
|
-1.2 Beats per minute
Standard Deviation 6.94
|
0.3 Beats per minute
Standard Deviation 5.01
|
-0.7 Beats per minute
Standard Deviation 5.99
|
0.5 Beats per minute
Standard Deviation 4.55
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Change at Day 304/ET
|
—
|
1.2 Beats per minute
Standard Deviation 5.88
|
-0.2 Beats per minute
Standard Deviation 2.56
|
2.0 Beats per minute
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ETPopulation: Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Baseline
|
36.40 Degree Celsius
Standard Deviation 0.228
|
36.72 Degree Celsius
Standard Deviation 0.256
|
36.87 Degree Celsius
Standard Deviation 0.082
|
36.72 Degree Celsius
Standard Deviation 0.397
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 1H post-dose Day 1
|
0.30 Degree Celsius
Standard Deviation 0.405
|
0.10 Degree Celsius
Standard Deviation 0.253
|
-0.10 Degree Celsius
Standard Deviation 0.190
|
0.08 Degree Celsius
Standard Deviation 0.183
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 4 H post-dose Day 1
|
0.18 Degree Celsius
Standard Deviation 0.571
|
0.08 Degree Celsius
Standard Deviation 0.133
|
0.03 Degree Celsius
Standard Deviation 0.207
|
0.17 Degree Celsius
Standard Deviation 0.327
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 24 H post-dose Day 2
|
0.22 Degree Celsius
Standard Deviation 0.204
|
0.12 Degree Celsius
Standard Deviation 0.232
|
-0.32 Degree Celsius
Standard Deviation 0.371
|
-0.08 Degree Celsius
Standard Deviation 0.515
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 7
|
0.15 Degree Celsius
Standard Deviation 0.226
|
0.05 Degree Celsius
Standard Deviation 0.315
|
-0.40 Degree Celsius
Standard Deviation 0.405
|
0.00 Degree Celsius
Standard Deviation 0.276
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 14
|
0.37 Degree Celsius
Standard Deviation 0.350
|
-0.03 Degree Celsius
Standard Deviation 0.327
|
0.08 Degree Celsius
Standard Deviation 0.117
|
0.05 Degree Celsius
Standard Deviation 0.243
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 19
|
0.43 Degree Celsius
Standard Deviation 0.234
|
-0.12 Degree Celsius
Standard Deviation 0.271
|
0.04 Degree Celsius
Standard Deviation 0.288
|
-0.02 Degree Celsius
Standard Deviation 0.183
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at pre-dose Day 28
|
0.18 Degree Celsius
Standard Deviation 0.204
|
-0.10 Degree Celsius
Standard Deviation 0.283
|
-0.02 Degree Celsius
Standard Deviation 0.172
|
-0.17 Degree Celsius
Standard Deviation 0.294
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 4-8 H post-dose Day 28
|
0.28 Degree Celsius
Standard Deviation 0.172
|
0.15 Degree Celsius
Standard Deviation 0.339
|
0.00 Degree Celsius
Standard Deviation 0.158
|
0.03 Degree Celsius
Standard Deviation 0.186
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 45
|
0.13 Degree Celsius
Standard Deviation 0.413
|
0.12 Degree Celsius
Standard Deviation 0.483
|
-0.06 Degree Celsius
Standard Deviation 0.195
|
0.03 Degree Celsius
Standard Deviation 0.516
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at pre-dose Day 56
|
0.05 Degree Celsius
Standard Deviation 0.476
|
0.08 Degree Celsius
Standard Deviation 0.366
|
0.03 Degree Celsius
Standard Deviation 0.175
|
0.07 Degree Celsius
Standard Deviation 0.350
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 4-8 H post-dose day 56
|
0.22 Degree Celsius
Standard Deviation 0.313
|
0.13 Degree Celsius
Standard Deviation 0.273
|
0.12 Degree Celsius
Standard Deviation 0.084
|
0.00 Degree Celsius
Standard Deviation 0.436
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 75
|
-0.15 Degree Celsius
Standard Deviation 0.437
|
0.07 Degree Celsius
Standard Deviation 0.333
|
-0.06 Degree Celsius
Standard Deviation 0.279
|
-0.28 Degree Celsius
Standard Deviation 0.383
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at pre-dose Day 84
|
-0.03 Degree Celsius
Standard Deviation 0.216
|
-0.03 Degree Celsius
Standard Deviation 0.320
|
0.02 Degree Celsius
Standard Deviation 0.147
|
-0.10 Degree Celsius
Standard Deviation 0.400
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 4-8 H post-dose Day 84
|
-0.13 Degree Celsius
Standard Deviation 0.665
|
0.00 Degree Celsius
Standard Deviation 0.167
|
0.03 Degree Celsius
Standard Deviation 0.103
|
0.10 Degree Celsius
Standard Deviation 0.274
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 103
|
0.05 Degree Celsius
Standard Deviation 0.394
|
-0.08 Degree Celsius
Standard Deviation 0.462
|
-0.10 Degree Celsius
Standard Deviation 0.219
|
-0.06 Degree Celsius
Standard Deviation 0.251
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at pre-dose Day 112
|
-0.08 Degree Celsius
Standard Deviation 0.512
|
0.12 Degree Celsius
Standard Deviation 0.279
|
-0.15 Degree Celsius
Standard Deviation 0.274
|
-0.20 Degree Celsius
Standard Deviation 0.292
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 4-8 H post-dose Day 112
|
0.03 Degree Celsius
Standard Deviation 0.437
|
0.12 Degree Celsius
Standard Deviation 0.387
|
-0.22 Degree Celsius
Standard Deviation 0.293
|
0.06 Degree Celsius
Standard Deviation 0.336
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 131
|
0.18 Degree Celsius
Standard Deviation 0.387
|
0.02 Degree Celsius
Standard Deviation 0.458
|
-0.14 Degree Celsius
Standard Deviation 0.288
|
-0.04 Degree Celsius
Standard Deviation 0.261
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at pre-dose Day 140
|
0.10 Degree Celsius
Standard Deviation 0.352
|
-0.05 Degree Celsius
Standard Deviation 0.432
|
-0.07 Degree Celsius
Standard Deviation 0.207
|
-0.02 Degree Celsius
Standard Deviation 0.311
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 1 H post-dose Day 140
|
0.02 Degree Celsius
Standard Deviation 0.496
|
0.08 Degree Celsius
Standard Deviation 0.407
|
-0.03 Degree Celsius
Standard Deviation 0.197
|
-0.30 Degree Celsius
Standard Deviation 0.224
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 4 H post dose Day 140
|
0.23 Degree Celsius
Standard Deviation 0.197
|
0.05 Degree Celsius
Standard Deviation 0.428
|
-0.12 Degree Celsius
Standard Deviation 0.248
|
-0.14 Degree Celsius
Standard Deviation 0.270
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at 24 H post dose Day 141
|
0.00 Degree Celsius
Standard Deviation 0.210
|
0.08 Degree Celsius
Standard Deviation 0.248
|
-0.18 Degree Celsius
Standard Deviation 0.183
|
-0.14 Degree Celsius
Standard Deviation 0.365
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 154
|
—
|
0.07 Degree Celsius
Standard Deviation 0.266
|
-0.25 Degree Celsius
Standard Deviation 0.414
|
0.00 Degree Celsius
Standard Deviation 0.141
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 168
|
0.27 Degree Celsius
Standard Deviation 0.459
|
-0.12 Degree Celsius
Standard Deviation 0.293
|
-0.18 Degree Celsius
Standard Deviation 0.264
|
0.12 Degree Celsius
Standard Deviation 0.192
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 224/ET
|
0.03 Degree Celsius
Standard Deviation 0.446
|
0.07 Degree Celsius
Standard Deviation 0.234
|
-0.07 Degree Celsius
Standard Deviation 0.288
|
0.03 Degree Celsius
Standard Deviation 0.472
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Change at Day 304/ET
|
—
|
-0.10 Degree Celsius
Standard Deviation 0.283
|
-0.10 Degree Celsius
Standard Deviation 0.167
|
-0.08 Degree Celsius
Standard Deviation 0.150
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ETPopulation: Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Baseline
|
81.74 Kilogram
Standard Deviation 9.975
|
85.85 Kilogram
Standard Deviation 8.443
|
78.58 Kilogram
Standard Deviation 12.497
|
80.14 Kilogram
Standard Deviation 21.430
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 19
|
0.25 Kilogram
Standard Deviation 0.709
|
-0.05 Kilogram
Standard Deviation 1.588
|
0.09 Kilogram
Standard Deviation 1.330
|
0.93 Kilogram
Standard Deviation 0.945
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 28
|
0.46 Kilogram
Standard Deviation 0.749
|
-0.12 Kilogram
Standard Deviation 2.098
|
0.02 Kilogram
Standard Deviation 1.172
|
0.29 Kilogram
Standard Deviation 0.661
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 45
|
0.71 Kilogram
Standard Deviation 1.654
|
-0.49 Kilogram
Standard Deviation 2.298
|
0.52 Kilogram
Standard Deviation 0.899
|
0.36 Kilogram
Standard Deviation 1.219
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 56
|
0.72 Kilogram
Standard Deviation 1.425
|
-0.99 Kilogram
Standard Deviation 2.371
|
-1.21 Kilogram
Standard Deviation 2.942
|
0.52 Kilogram
Standard Deviation 0.616
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 75
|
0.60 Kilogram
Standard Deviation 1.464
|
-0.46 Kilogram
Standard Deviation 3.267
|
0.48 Kilogram
Standard Deviation 0.883
|
0.98 Kilogram
Standard Deviation 0.641
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 84
|
0.63 Kilogram
Standard Deviation 1.538
|
-0.54 Kilogram
Standard Deviation 3.194
|
-0.16 Kilogram
Standard Deviation 0.943
|
0.99 Kilogram
Standard Deviation 1.050
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 103
|
-0.60 Kilogram
Standard Deviation 4.787
|
-0.75 Kilogram
Standard Deviation 3.213
|
0.22 Kilogram
Standard Deviation 1.249
|
1.23 Kilogram
Standard Deviation 1.490
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 112
|
0.67 Kilogram
Standard Deviation 1.118
|
0.05 Kilogram
Standard Deviation 3.638
|
-0.05 Kilogram
Standard Deviation 0.731
|
1.43 Kilogram
Standard Deviation 1.097
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 131
|
1.35 Kilogram
Standard Deviation 1.354
|
-0.43 Kilogram
Standard Deviation 4.197
|
-0.08 Kilogram
Standard Deviation 0.646
|
1.67 Kilogram
Standard Deviation 1.159
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 140
|
1.06 Kilogram
Standard Deviation 0.833
|
-0.36 Kilogram
Standard Deviation 4.233
|
-0.46 Kilogram
Standard Deviation 1.248
|
1.37 Kilogram
Standard Deviation 1.708
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 154
|
—
|
-3.78 Kilogram
Standard Deviation 8.246
|
-0.57 Kilogram
Standard Deviation 1.301
|
1.03 Kilogram
Standard Deviation 1.464
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 168
|
1.74 Kilogram
Standard Deviation 2.723
|
-1.35 Kilogram
Standard Deviation 4.393
|
-0.84 Kilogram
Standard Deviation 1.237
|
1.26 Kilogram
Standard Deviation 1.312
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 224/ ET
|
0.85 Kilogram
Standard Deviation 0.976
|
-1.97 Kilogram
Standard Deviation 4.284
|
1.49 Kilogram
Standard Deviation 4.376
|
1.42 Kilogram
Standard Deviation 1.679
|
|
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Change at Day 304/ET
|
—
|
0.71 Kilogram
Standard Deviation 6.545
|
3.04 Kilogram
Standard Deviation 4.327
|
0.60 Kilogram
Standard Deviation 0.678
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ETPopulation: Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Criteria for changes in ECG (12-lead) were defined as: PR interval \>=220 millisecond (msec) and increase of \>=20 msec; QRS interval \>=120 msec; QT interval corrected using the Bazett's formula (QTcB) \>=500 msec; Maximum Change from Baseline in QTcF at Borderline \>=30 msec to \<60 msec and Prolonged \>=60 msec.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post dose Day 140: QTcB
|
0.72 Millisecond
Standard Deviation 9.525
|
1.83 Millisecond
Standard Deviation 9.697
|
9.06 Millisecond
Standard Deviation 11.144
|
11.80 Millisecond
Standard Deviation 20.895
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: QTcB
|
-6.39 Millisecond
Standard Deviation 18.637
|
1.33 Millisecond
Standard Deviation 13.471
|
4.06 Millisecond
Standard Deviation 10.810
|
10.07 Millisecond
Standard Deviation 21.177
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: QTcB
|
-5.39 Millisecond
Standard Deviation 11.496
|
-12.33 Millisecond
Standard Deviation 13.105
|
3.72 Millisecond
Standard Deviation 14.188
|
6.72 Millisecond
Standard Deviation 17.425
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: QTcB
|
—
|
-9.5 Millisecond
Standard Deviation 15.812
|
-6.28 Millisecond
Standard Deviation 17.655
|
13.17 Millisecond
Standard Deviation 8.813
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: RR
|
939.28 Millisecond
Standard Deviation 124.486
|
962.44 Millisecond
Standard Deviation 117.246
|
918.39 Millisecond
Standard Deviation 101.325
|
928.33 Millisecond
Standard Deviation 117.701
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 1: RR
|
4.06 Millisecond
Standard Deviation 45.449
|
24.94 Millisecond
Standard Deviation 70.632
|
79.11 Millisecond
Standard Deviation 89.729
|
-21.22 Millisecond
Standard Deviation 136.555
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post-dose Day 1: RR
|
-36.28 Millisecond
Standard Deviation 38.148
|
-34.22 Millisecond
Standard Deviation 82.327
|
22.33 Millisecond
Standard Deviation 115.576
|
-54.11 Millisecond
Standard Deviation 94.978
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 28: RR
|
29.56 Millisecond
Standard Deviation 40.059
|
0.39 Millisecond
Standard Deviation 53.575
|
69.44 Millisecond
Standard Deviation 91.732
|
49.00 Millisecond
Standard Deviation 78.316
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 56: RR
|
5.39 Millisecond
Standard Deviation 61.533
|
-19.78 Millisecond
Standard Deviation 32.654
|
74.78 Millisecond
Standard Deviation 98.804
|
8.83 Millisecond
Standard Deviation 65.440
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 84: RR
|
-7.61 Millisecond
Standard Deviation 53.735
|
-12.78 Millisecond
Standard Deviation 56.646
|
57.11 Millisecond
Standard Deviation 102.514
|
-51.67 Millisecond
Standard Deviation 186.668
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 112: RR
|
30.56 Millisecond
Standard Deviation 23.478
|
-24.11 Millisecond
Standard Deviation 63.637
|
34.94 Millisecond
Standard Deviation 77.744
|
-44.87 Millisecond
Standard Deviation 82.091
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 140: RR
|
-6.39 Millisecond
Standard Deviation 43.272
|
-39.89 Millisecond
Standard Deviation 85.486
|
26.56 Millisecond
Standard Deviation 91.107
|
-9.60 Millisecond
Standard Deviation 51.462
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 140: RR
|
-6.78 Millisecond
Standard Deviation 120.518
|
-16.83 Millisecond
Standard Deviation 58.974
|
80.44 Millisecond
Standard Deviation 104.487
|
42.60 Millisecond
Standard Deviation 150.052
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post dose Day 140: RR
|
-44.61 Millisecond
Standard Deviation 76.284
|
-66.17 Millisecond
Standard Deviation 86.676
|
52.17 Millisecond
Standard Deviation 86.145
|
5.13 Millisecond
Standard Deviation 166.054
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: RR
|
-33.11 Millisecond
Standard Deviation 80.934
|
-31.78 Millisecond
Standard Deviation 27.507
|
60.44 Millisecond
Standard Deviation 122.291
|
-28.67 Millisecond
Standard Deviation 70.982
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: RR
|
21.72 Millisecond
Standard Deviation 77.289
|
8.89 Millisecond
Standard Deviation 58.224
|
-22.72 Millisecond
Standard Deviation 99.733
|
56.50 Millisecond
Standard Deviation 78.870
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: RR
|
—
|
32.39 Millisecond
Standard Deviation 70.600
|
-9.22 Millisecond
Standard Deviation 80.263
|
-11.92 Millisecond
Standard Deviation 122.446
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: PR
|
170.78 Millisecond
Standard Deviation 23.268
|
190.00 Millisecond
Standard Deviation 38.006
|
167.89 Millisecond
Standard Deviation 25.711
|
166.11 Millisecond
Standard Deviation 41.177
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 1: PR
|
-4.22 Millisecond
Standard Deviation 13.589
|
-4.33 Millisecond
Standard Deviation 9.407
|
-7.11 Millisecond
Standard Deviation 12.261
|
-2.67 Millisecond
Standard Deviation 6.902
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post-dose Day 1: PR
|
-1.33 Millisecond
Standard Deviation 9.762
|
-4.89 Millisecond
Standard Deviation 6.898
|
-6.33 Millisecond
Standard Deviation 7.563
|
-2.89 Millisecond
Standard Deviation 6.362
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 28: PR
|
-2.78 Millisecond
Standard Deviation 11.711
|
1.00 Millisecond
Standard Deviation 10.673
|
28.44 Millisecond
Standard Deviation 84.486
|
3.89 Millisecond
Standard Deviation 12.245
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 56: PR
|
-6.78 Millisecond
Standard Deviation 9.270
|
0.33 Millisecond
Standard Deviation 15.842
|
-11.47 Millisecond
Standard Deviation 22.912
|
12.22 Millisecond
Standard Deviation 23.512
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 84: PR
|
0.22 Millisecond
Standard Deviation 6.885
|
-8.33 Millisecond
Standard Deviation 18.426
|
-0.67 Millisecond
Standard Deviation 1.944
|
11.73 Millisecond
Standard Deviation 32.392
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 112: PR
|
-0.78 Millisecond
Standard Deviation 12.567
|
-3.33 Millisecond
Standard Deviation 18.086
|
-13.56 Millisecond
Standard Deviation 22.134
|
16.53 Millisecond
Standard Deviation 26.764
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 140: PR
|
2.33 Millisecond
Standard Deviation 8.892
|
-1.11 Millisecond
Standard Deviation 14.052
|
-4.22 Millisecond
Standard Deviation 5.311
|
11.33 Millisecond
Standard Deviation 23.636
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 140: PR
|
-3.33 Millisecond
Standard Deviation 7.760
|
-1.56 Millisecond
Standard Deviation 11.938
|
-4.67 Millisecond
Standard Deviation 14.569
|
16.27 Millisecond
Standard Deviation 22.229
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post dose Day 140: PR
|
-4.33 Millisecond
Standard Deviation 9.177
|
2.00 Millisecond
Standard Deviation 8.316
|
-7.89 Millisecond
Standard Deviation 11.262
|
21.87 Millisecond
Standard Deviation 28.757
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: PR
|
-4.11 Millisecond
Standard Deviation 8.405
|
-7.00 Millisecond
Standard Deviation 12.994
|
-2.56 Millisecond
Standard Deviation 5.154
|
-1.50 Millisecond
Standard Deviation 10.932
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: PR
|
-7.11 Millisecond
Standard Deviation 14.090
|
-1.00 Millisecond
Standard Deviation 15.468
|
-7.89 Millisecond
Standard Deviation 7.061
|
14.13 Millisecond
Standard Deviation 24.214
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: PR
|
—
|
-3.00 Millisecond
Standard Deviation 19.066
|
-17.22 Millisecond
Standard Deviation 21.935
|
16.33 Millisecond
Standard Deviation 21.709
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: QRS
|
87.11 Millisecond
Standard Deviation 5.036
|
91.44 Millisecond
Standard Deviation 8.352
|
97.89 Millisecond
Standard Deviation 22.444
|
100.33 Millisecond
Standard Deviation 24.858
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 1: QRS
|
-2.67 Millisecond
Standard Deviation 4.881
|
-1.56 Millisecond
Standard Deviation 3.417
|
-2.33 Millisecond
Standard Deviation 2.789
|
0.78 Millisecond
Standard Deviation 1.760
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post-dose Day 1: QRS
|
-1.78 Millisecond
Standard Deviation 4.856
|
-1.67 Millisecond
Standard Deviation 2.692
|
0.44 Millisecond
Standard Deviation 2.373
|
0.78 Millisecond
Standard Deviation 3.410
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 28: QRS
|
1.56 Millisecond
Standard Deviation 4.375
|
-1.44 Millisecond
Standard Deviation 3.410
|
-0.89 Millisecond
Standard Deviation 2.656
|
-0.33 Millisecond
Standard Deviation 2.261
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 56: QRS
|
-1.44 Millisecond
Standard Deviation 2.083
|
0.22 Millisecond
Standard Deviation 5.054
|
1.78 Millisecond
Standard Deviation 2.722
|
-2.67 Millisecond
Standard Deviation 6.037
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 84: QRS
|
-2.11 Millisecond
Standard Deviation 3.331
|
-0.11 Millisecond
Standard Deviation 6.217
|
6.78 Millisecond
Standard Deviation 22.333
|
1.60 Millisecond
Standard Deviation 9.541
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 112: QRS
|
-3.11 Millisecond
Standard Deviation 7.101
|
1.56 Millisecond
Standard Deviation 4.593
|
5.11 Millisecond
Standard Deviation 20.149
|
0.80 Millisecond
Standard Deviation 4.840
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 140: QRS
|
-2.67 Millisecond
Standard Deviation 4.638
|
1.22 Millisecond
Standard Deviation 5.439
|
0.33 Millisecond
Standard Deviation 2.883
|
-0.40 Millisecond
Standard Deviation 4.017
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 140: QRS
|
-2.56 Millisecond
Standard Deviation 3.538
|
0.67 Millisecond
Standard Deviation 6.613
|
1.22 Millisecond
Standard Deviation 2.083
|
0.40 Millisecond
Standard Deviation 4.681
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post dose Day 140: QRS
|
-2.22 Millisecond
Standard Deviation 3.202
|
-0.22 Millisecond
Standard Deviation 4.456
|
-0.44 Millisecond
Standard Deviation 1.440
|
2.53 Millisecond
Standard Deviation 5.586
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: QRS
|
-4.44 Millisecond
Standard Deviation 5.106
|
1.89 Millisecond
Standard Deviation 5.340
|
2.11 Millisecond
Standard Deviation 4.530
|
0.00 Millisecond
Standard Deviation 4.922
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: QRS
|
-2.44 Millisecond
Standard Deviation 6.017
|
0.22 Millisecond
Standard Deviation 3.569
|
9.78 Millisecond
Standard Deviation 26.712
|
1.00 Millisecond
Standard Deviation 2.692
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: QRS
|
—
|
1.22 Millisecond
Standard Deviation 6.895
|
-2.56 Millisecond
Standard Deviation 1.760
|
5.83 Millisecond
Standard Deviation 4.631
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: QT
|
405.00 Millisecond
Standard Deviation 25.174
|
422.00 Millisecond
Standard Deviation 29.835
|
408.56 Millisecond
Standard Deviation 30.560
|
401.78 Millisecond
Standard Deviation 31.932
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1H post-dose Day 1: QT
|
1.22 Millisecond
Standard Deviation 14.270
|
2.22 Millisecond
Standard Deviation 11.713
|
14.22 Millisecond
Standard Deviation 14.845
|
0.78 Millisecond
Standard Deviation 26.346
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post-dose Day 1: QT
|
-3.78 Millisecond
Standard Deviation 18.493
|
-13.44 Millisecond
Standard Deviation 19.018
|
4.67 Millisecond
Standard Deviation 29.796
|
1.56 Millisecond
Standard Deviation 32.457
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 28: QT
|
-1.33 Millisecond
Standard Deviation 13.367
|
-11.33 Millisecond
Standard Deviation 17.420
|
11.11 Millisecond
Standard Deviation 14.228
|
4.89 Millisecond
Standard Deviation 18.290
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 56: QT
|
-2.33 Millisecond
Standard Deviation 11.939
|
-8.67 Millisecond
Standard Deviation 10.302
|
18.44 Millisecond
Standard Deviation 31.865
|
8.22 Millisecond
Standard Deviation 10.221
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 84: QT
|
-2.33 Millisecond
Standard Deviation 15.769
|
-11.33 Millisecond
Standard Deviation 13.914
|
14.11 Millisecond
Standard Deviation 26.319
|
10.27 Millisecond
Standard Deviation 28.482
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 112: QT
|
-1.00 Millisecond
Standard Deviation 5.379
|
-9.33 Millisecond
Standard Deviation 17.420
|
5.44 Millisecond
Standard Deviation 13.607
|
19.07 Millisecond
Standard Deviation 35.345
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 140: QT
|
-3.44 Millisecond
Standard Deviation 12.274
|
-6.00 Millisecond
Standard Deviation 14.092
|
11.89 Millisecond
Standard Deviation 18.621
|
7.47 Millisecond
Standard Deviation 25.304
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 140: QT
|
-4.67 Millisecond
Standard Deviation 24.909
|
-18.00 Millisecond
Standard Deviation 35.700
|
22.33 Millisecond
Standard Deviation 22.170
|
19.33 Millisecond
Standard Deviation 28.091
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post dose Day 140: QT
|
-10.22 Millisecond
Standard Deviation 12.174
|
-13.00 Millisecond
Standard Deviation 17.006
|
19.67 Millisecond
Standard Deviation 14.340
|
11.33 Millisecond
Standard Deviation 35.308
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: QT
|
-13.00 Millisecond
Standard Deviation 17.255
|
-5.67 Millisecond
Standard Deviation 11.939
|
16.44 Millisecond
Standard Deviation 36.302
|
4.27 Millisecond
Standard Deviation 26.594
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: QT
|
-1.67 Millisecond
Standard Deviation 6.782
|
-9.67 Millisecond
Standard Deviation 12.442
|
-1.22 Millisecond
Standard Deviation 27.995
|
19.22 Millisecond
Standard Deviation 22.225
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: QT
|
—
|
-1.67 Millisecond
Standard Deviation 16.896
|
-8.56 Millisecond
Standard Deviation 31.792
|
9.33 Millisecond
Standard Deviation 36.127
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: QTcB
|
418.56 Millisecond
Standard Deviation 13.605
|
430.67 Millisecond
Standard Deviation 20.976
|
426.28 Millisecond
Standard Deviation 18.370
|
417.11 Millisecond
Standard Deviation 17.539
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 1: QTcB
|
0.39 Millisecond
Standard Deviation 4.823
|
-3.50 Millisecond
Standard Deviation 6.483
|
-2.67 Millisecond
Standard Deviation 12.006
|
5.81 Millisecond
Standard Deviation 17.269
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post-dose Day 1: QTcB
|
4.44 Millisecond
Standard Deviation 13.274
|
-6.67 Millisecond
Standard Deviation 14.188
|
-0.11 Millisecond
Standard Deviation 6.811
|
13.50 Millisecond
Standard Deviation 29.257
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 28: QTcB
|
-6.39 Millisecond
Standard Deviation 17.989
|
-12.50 Millisecond
Standard Deviation 14.442
|
-2.94 Millisecond
Standard Deviation 18.639
|
-5.94 Millisecond
Standard Deviation 5.953
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 56: QTcB
|
-2.06 Millisecond
Standard Deviation 16.679
|
-4.67 Millisecond
Standard Deviation 9.920
|
1.56 Millisecond
Standard Deviation 15.450
|
5.39 Millisecond
Standard Deviation 19.841
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 84: QTcB
|
-0.89 Millisecond
Standard Deviation 8.516
|
-9.33 Millisecond
Standard Deviation 16.350
|
2.22 Millisecond
Standard Deviation 21.281
|
23.07 Millisecond
Standard Deviation 32.116
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 112: QTcB
|
-6.89 Millisecond
Standard Deviation 9.135
|
-4.33 Millisecond
Standard Deviation 8.899
|
-1.11 Millisecond
Standard Deviation 9.660
|
29.07 Millisecond
Standard Deviation 42.361
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 140: QTcB
|
-2.11 Millisecond
Standard Deviation 6.493
|
3.17 Millisecond
Standard Deviation 11.201
|
6.94 Millisecond
Standard Deviation 6.641
|
9.33 Millisecond
Standard Deviation 22.955
|
|
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 140: QTcB
|
-0.61 Millisecond
Standard Deviation 9.855
|
-14.78 Millisecond
Standard Deviation 38.322
|
4.72 Millisecond
Standard Deviation 10.794
|
11.33 Millisecond
Standard Deviation 18.318
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET
|
-0.61 Beats per minute
Standard Deviation 5.031
|
-0.67 Beats per minute
Standard Deviation 4.279
|
1.11 Beats per minute
Standard Deviation 7.067
|
-3.44 Beats per minute
Standard Deviation 5.730
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline
|
64.94 Beats per minute
Standard Deviation 9.318
|
63.17 Beats per minute
Standard Deviation 7.327
|
66.06 Beats per minute
Standard Deviation 7.295
|
65.44 Beats per minute
Standard Deviation 7.556
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 1
|
-0.33 Beats per minute
Standard Deviation 3.026
|
-1.67 Beats per minute
Standard Deviation 4.142
|
-5.44 Beats per minute
Standard Deviation 6.527
|
2.72 Beats per minute
Standard Deviation 10.603
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post-dose Day 1
|
2.28 Beats per minute
Standard Deviation 2.752
|
2.11 Beats per minute
Standard Deviation 5.188
|
-1.72 Beats per minute
Standard Deviation 8.045
|
4.00 Beats per minute
Standard Deviation 7.226
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 28
|
-1.78 Beats per minute
Standard Deviation 2.562
|
-0.17 Beats per minute
Standard Deviation 3.475
|
-4.39 Beats per minute
Standard Deviation 5.463
|
-3.78 Beats per minute
Standard Deviation 5.496
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 56
|
0.39 Beats per minute
Standard Deviation 4.096
|
1.17 Beats per minute
Standard Deviation 1.810
|
-4.89 Beats per minute
Standard Deviation 7.290
|
-1.11 Beats per minute
Standard Deviation 4.617
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 84
|
0.22 Beats per minute
Standard Deviation 3.410
|
0.50 Beats per minute
Standard Deviation 3.378
|
-3.72 Beats per minute
Standard Deviation 6.191
|
4.00 Beats per minute
Standard Deviation 12.243
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 112
|
-1.78 Beats per minute
Standard Deviation 1.559
|
1.33 Beats per minute
Standard Deviation 4.580
|
-1.89 Beats per minute
Standard Deviation 3.959
|
3.00 Beats per minute
Standard Deviation 6.342
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 140
|
0.50 Beats per minute
Standard Deviation 2.606
|
2.89 Beats per minute
Standard Deviation 5.556
|
-1.39 Beats per minute
Standard Deviation 6.591
|
0.93 Beats per minute
Standard Deviation 3.919
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 140
|
2.61 Beats per minute
Standard Deviation 11.432
|
1.17 Beats per minute
Standard Deviation 3.650
|
-5.22 Beats per minute
Standard Deviation 6.649
|
-2.13 Beats per minute
Standard Deviation 10.038
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post dose Day 140
|
3.67 Beats per minute
Standard Deviation 5.578
|
5.11 Beats per minute
Standard Deviation 6.869
|
-3.61 Beats per minute
Standard Deviation 5.752
|
0.47 Beats per minute
Standard Deviation 12.613
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168
|
2.22 Beats per minute
Standard Deviation 5.419
|
2.00 Beats per minute
Standard Deviation 1.687
|
-3.56 Beats per minute
Standard Deviation 7.745
|
2.20 Beats per minute
Standard Deviation 5.316
|
|
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET
|
—
|
-2.50 Beats per minute
Standard Deviation 4.451
|
0.94 Beats per minute
Standard Deviation 6.220
|
3.08 Beats per minute
Standard Deviation 9.094
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point. Categories with at least 1 non-zero data have been provided below.
Following parameters were analyzed for laboratory examination: Bilirubin, Direct Bilirubin, Blood Urea Nitrogen(BUN), Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol (CL)(Fasting), Triglycerides (Fasting) (TG), Immunoglobulin G (Ig G), Immunoglobulin A (Ig A), Immunoglobulin M (Ig M)
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Bilirubin
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.075
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.200
|
0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.423
|
-0.08 Milligram per deciliter (MG/DL)
Standard Deviation 0.192
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Bilirubin
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.082
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.210
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.133
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.163
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Bilirubin
|
—
|
0.05 Milligram per deciliter (MG/DL)
Standard Deviation 0.105
|
0.20 Milligram per deciliter (MG/DL)
Standard Deviation 0.415
|
-0.05 Milligram per deciliter (MG/DL)
Standard Deviation 0.100
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Glucose
|
-2.0 Milligram per deciliter (MG/DL)
Standard Deviation 1.41
|
7.2 Milligram per deciliter (MG/DL)
Standard Deviation 12.56
|
7.5 Milligram per deciliter (MG/DL)
Standard Deviation 11.47
|
7.8 Milligram per deciliter (MG/DL)
Standard Deviation 13.35
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: BUN
|
18.7 Milligram per deciliter (MG/DL)
Standard Deviation 5.01
|
15.5 Milligram per deciliter (MG/DL)
Standard Deviation 3.89
|
18.8 Milligram per deciliter (MG/DL)
Standard Deviation 3.87
|
23.3 Milligram per deciliter (MG/DL)
Standard Deviation 8.33
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Glucose
|
4.7 Milligram per deciliter (MG/DL)
Standard Deviation 5.28
|
7.3 Milligram per deciliter (MG/DL)
Standard Deviation 12.13
|
9.2 Milligram per deciliter (MG/DL)
Standard Deviation 11.58
|
3.6 Milligram per deciliter (MG/DL)
Standard Deviation 10.67
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Glucose
|
6.8 Milligram per deciliter (MG/DL)
Standard Deviation 4.88
|
6.3 Milligram per deciliter (MG/DL)
Standard Deviation 12.04
|
17.7 Milligram per deciliter (MG/DL)
Standard Deviation 7.69
|
11.0 Milligram per deciliter (MG/DL)
Standard Deviation 14.61
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Glucose
|
-1.0 Milligram per deciliter (MG/DL)
Standard Deviation 6.42
|
3.2 Milligram per deciliter (MG/DL)
Standard Deviation 6.11
|
12.5 Milligram per deciliter (MG/DL)
Standard Deviation 14.79
|
17.6 Milligram per deciliter (MG/DL)
Standard Deviation 32.65
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: BUN
|
-0.3 Milligram per deciliter (MG/DL)
Standard Deviation 3.14
|
-0.2 Milligram per deciliter (MG/DL)
Standard Deviation 2.64
|
0.5 Milligram per deciliter (MG/DL)
Standard Deviation 7.14
|
1.5 Milligram per deciliter (MG/DL)
Standard Deviation 3.73
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: BUN
|
-2.0 Milligram per deciliter (MG/DL)
Standard Deviation 2.10
|
-1.2 Milligram per deciliter (MG/DL)
Standard Deviation 4.62
|
2.7 Milligram per deciliter (MG/DL)
Standard Deviation 1.63
|
0.0 Milligram per deciliter (MG/DL)
Standard Deviation 4.52
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: BUN
|
1.2 Milligram per deciliter (MG/DL)
Standard Deviation 2.14
|
1.3 Milligram per deciliter (MG/DL)
Standard Deviation 2.80
|
0.8 Milligram per deciliter (MG/DL)
Standard Deviation 2.93
|
-0.5 Milligram per deciliter (MG/DL)
Standard Deviation 8.87
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Glucose
|
0.7 Milligram per deciliter (MG/DL)
Standard Deviation 6.28
|
3.3 Milligram per deciliter (MG/DL)
Standard Deviation 5.85
|
8.5 Milligram per deciliter (MG/DL)
Standard Deviation 12.85
|
7.2 Milligram per deciliter (MG/DL)
Standard Deviation 28.03
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: TG (fasting)
|
-24.5 Milligram per deciliter (MG/DL)
Standard Deviation 46.00
|
-18.0 Milligram per deciliter (MG/DL)
Standard Deviation 54.98
|
-13.8 Milligram per deciliter (MG/DL)
Standard Deviation 22.68
|
-58.0 Milligram per deciliter (MG/DL)
Standard Deviation 77.36
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: BUN
|
1.3 Milligram per deciliter (MG/DL)
Standard Deviation 4.32
|
1.3 Milligram per deciliter (MG/DL)
Standard Deviation 3.78
|
-0.2 Milligram per deciliter (MG/DL)
Standard Deviation 5.98
|
-3.6 Milligram per deciliter (MG/DL)
Standard Deviation 7.02
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Glucose
|
—
|
5.8 Milligram per deciliter (MG/DL)
Standard Deviation 12.16
|
3.8 Milligram per deciliter (MG/DL)
Standard Deviation 15.69
|
20.3 Milligram per deciliter (MG/DL)
Standard Deviation 50.70
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: CL (fasting)
|
191.7 Milligram per deciliter (MG/DL)
Standard Deviation 20.34
|
188.7 Milligram per deciliter (MG/DL)
Standard Deviation 60.01
|
196.5 Milligram per deciliter (MG/DL)
Standard Deviation 48.19
|
194.2 Milligram per deciliter (MG/DL)
Standard Deviation 33.71
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: CL (fasting)
|
-9.0 Milligram per deciliter (MG/DL)
Standard Deviation 13.28
|
2.7 Milligram per deciliter (MG/DL)
Standard Deviation 15.12
|
-10.8 Milligram per deciliter (MG/DL)
Standard Deviation 12.63
|
13.3 Milligram per deciliter (MG/DL)
Standard Deviation 27.09
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: CL (fasting)
|
12.3 Milligram per deciliter (MG/DL)
Standard Deviation 14.19
|
-10.2 Milligram per deciliter (MG/DL)
Standard Deviation 15.79
|
1.7 Milligram per deciliter (MG/DL)
Standard Deviation 12.89
|
8.0 Milligram per deciliter (MG/DL)
Standard Deviation 42.82
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: CL (fasting)
|
0.0 Milligram per deciliter (MG/DL)
Standard Deviation 8.02
|
1.5 Milligram per deciliter (MG/DL)
Standard Deviation 9.57
|
-2.2 Milligram per deciliter (MG/DL)
Standard Deviation 10.80
|
-2.4 Milligram per deciliter (MG/DL)
Standard Deviation 23.20
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: CL (fasting)
|
-6.5 Milligram per deciliter (MG/DL)
Standard Deviation 35.23
|
-5.8 Milligram per deciliter (MG/DL)
Standard Deviation 7.99
|
0.7 Milligram per deciliter (MG/DL)
Standard Deviation 19.05
|
-7.2 Milligram per deciliter (MG/DL)
Standard Deviation 18.86
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: BUN
|
-0.2 Milligram per deciliter (MG/DL)
Standard Deviation 5.08
|
-0.5 Milligram per deciliter (MG/DL)
Standard Deviation 2.74
|
1.7 Milligram per deciliter (MG/DL)
Standard Deviation 4.27
|
-1.0 Milligram per deciliter (MG/DL)
Standard Deviation 7.62
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: CL (fasting)
|
-2.5 Milligram per deciliter (MG/DL)
Standard Deviation 17.13
|
0.3 Milligram per deciliter (MG/DL)
Standard Deviation 15.23
|
4.2 Milligram per deciliter (MG/DL)
Standard Deviation 10.67
|
-5.4 Milligram per deciliter (MG/DL)
Standard Deviation 33.06
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: BUN
|
1.0 Milligram per deciliter (MG/DL)
Standard Deviation 4.60
|
-0.2 Milligram per deciliter (MG/DL)
Standard Deviation 4.07
|
1.3 Milligram per deciliter (MG/DL)
Standard Deviation 2.42
|
-1.6 Milligram per deciliter (MG/DL)
Standard Deviation 5.41
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: CL (fasting)
|
-0.8 Milligram per deciliter (MG/DL)
Standard Deviation 26.54
|
-2.5 Milligram per deciliter (MG/DL)
Standard Deviation 8.57
|
-12.5 Milligram per deciliter (MG/DL)
Standard Deviation 21.68
|
13.0 Milligram per deciliter (MG/DL)
Standard Deviation 37.90
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: CL (fasting)
|
-4.7 Milligram per deciliter (MG/DL)
Standard Deviation 19.79
|
0.2 Milligram per deciliter (MG/DL)
Standard Deviation 10.72
|
-11.8 Milligram per deciliter (MG/DL)
Standard Deviation 24.34
|
7.2 Milligram per deciliter (MG/DL)
Standard Deviation 40.49
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: CL (fasting)
|
—
|
1.3 Milligram per deciliter (MG/DL)
Standard Deviation 19.28
|
-3.5 Milligram per deciliter (MG/DL)
Standard Deviation 13.88
|
-1.3 Milligram per deciliter (MG/DL)
Standard Deviation 29.34
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: TG (fasting)
|
141.7 Milligram per deciliter (MG/DL)
Standard Deviation 47.32
|
138.5 Milligram per deciliter (MG/DL)
Standard Deviation 58.95
|
110.5 Milligram per deciliter (MG/DL)
Standard Deviation 41.40
|
195.2 Milligram per deciliter (MG/DL)
Standard Deviation 149.85
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: TG (fasting)
|
-23.2 Milligram per deciliter (MG/DL)
Standard Deviation 35.44
|
4.0 Milligram per deciliter (MG/DL)
Standard Deviation 68.07
|
-9.3 Milligram per deciliter (MG/DL)
Standard Deviation 34.91
|
-8.0 Milligram per deciliter (MG/DL)
Standard Deviation 37.31
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Uric Acid
|
0.62 Milligram per deciliter (MG/DL)
Standard Deviation 1.072
|
0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.662
|
0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.836
|
0.48 Milligram per deciliter (MG/DL)
Standard Deviation 0.933
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: TG (fasting)
|
4.2 Milligram per deciliter (MG/DL)
Standard Deviation 63.29
|
-24.7 Milligram per deciliter (MG/DL)
Standard Deviation 57.41
|
-8.2 Milligram per deciliter (MG/DL)
Standard Deviation 23.51
|
-49.5 Milligram per deciliter (MG/DL)
Standard Deviation 124.64
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Uric Acid
|
—
|
0.32 Milligram per deciliter (MG/DL)
Standard Deviation 0.677
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 1.143
|
-0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.510
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: BUN
|
0.0 Milligram per deciliter (MG/DL)
Standard Deviation 2.45
|
0.5 Milligram per deciliter (MG/DL)
Standard Deviation 3.51
|
1.0 Milligram per deciliter (MG/DL)
Standard Deviation 3.46
|
-1.2 Milligram per deciliter (MG/DL)
Standard Deviation 6.76
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: TG (fasting)
|
2.2 Milligram per deciliter (MG/DL)
Standard Deviation 38.57
|
-18.0 Milligram per deciliter (MG/DL)
Standard Deviation 43.32
|
-19.7 Milligram per deciliter (MG/DL)
Standard Deviation 18.22
|
-98.4 Milligram per deciliter (MG/DL)
Standard Deviation 140.73
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: TG (fasting)
|
6.0 Milligram per deciliter (MG/DL)
Standard Deviation 73.16
|
-16.5 Milligram per deciliter (MG/DL)
Standard Deviation 32.31
|
-2.8 Milligram per deciliter (MG/DL)
Standard Deviation 23.76
|
-89.0 Milligram per deciliter (MG/DL)
Standard Deviation 146.53
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: TG (fasting)
|
-15.0 Milligram per deciliter (MG/DL)
Standard Deviation 45.79
|
-13.7 Milligram per deciliter (MG/DL)
Standard Deviation 50.39
|
-7.5 Milligram per deciliter (MG/DL)
Standard Deviation 29.13
|
-67.6 Milligram per deciliter (MG/DL)
Standard Deviation 84.14
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: TG (fasting)
|
-11.5 Milligram per deciliter (MG/DL)
Standard Deviation 43.72
|
-7.3 Milligram per deciliter (MG/DL)
Standard Deviation 26.30
|
-4.2 Milligram per deciliter (MG/DL)
Standard Deviation 24.13
|
-52.2 Milligram per deciliter (MG/DL)
Standard Deviation 151.28
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: TG (fasting)
|
—
|
-18.5 Milligram per deciliter (MG/DL)
Standard Deviation 31.17
|
0.5 Milligram per deciliter (MG/DL)
Standard Deviation 26.94
|
-42.0 Milligram per deciliter (MG/DL)
Standard Deviation 168.16
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: lg G
|
—
|
—
|
840.5 Milligram per deciliter (MG/DL)
Standard Deviation 171.08
|
793.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: lg G
|
—
|
—
|
42.7 Milligram per deciliter (MG/DL)
Standard Deviation 26.63
|
—
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: lg G
|
—
|
—
|
69.7 Milligram per deciliter (MG/DL)
Standard Deviation 65.83
|
-30.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: lg G
|
—
|
—
|
41.8 Milligram per deciliter (MG/DL)
Standard Deviation 72.02
|
-40.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: lg A
|
—
|
—
|
257.3 Milligram per deciliter (MG/DL)
Standard Deviation 108.27
|
299.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: lg A
|
—
|
—
|
7.0 Milligram per deciliter (MG/DL)
Standard Deviation 7.55
|
—
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: lg A
|
—
|
—
|
-10.0 Milligram per deciliter (MG/DL)
Standard Deviation 14.56
|
-25.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: lg A
|
—
|
—
|
-4.2 Milligram per deciliter (MG/DL)
Standard Deviation 26.36
|
-25.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: lg M
|
—
|
—
|
101.0 Milligram per deciliter (MG/DL)
Standard Deviation 60.79
|
58.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: lg M
|
—
|
—
|
9.7 Milligram per deciliter (MG/DL)
Standard Deviation 8.74
|
—
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: lg M
|
—
|
—
|
4.7 Milligram per deciliter (MG/DL)
Standard Deviation 7.06
|
-6.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: lg M
|
—
|
—
|
8.2 Milligram per deciliter (MG/DL)
Standard Deviation 19.69
|
-9.0 Milligram per deciliter (MG/DL)
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: BUN
|
—
|
1.5 Milligram per deciliter (MG/DL)
Standard Deviation 2.59
|
2.3 Milligram per deciliter (MG/DL)
Standard Deviation 4.63
|
-3.5 Milligram per deciliter (MG/DL)
Standard Deviation 6.35
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Creatinine
|
0.055 Milligram per deciliter (MG/DL)
Standard Deviation 0.1710
|
-0.020 Milligram per deciliter (MG/DL)
Standard Deviation 0.1271
|
0.035 Milligram per deciliter (MG/DL)
Standard Deviation 0.0742
|
0.002 Milligram per deciliter (MG/DL)
Standard Deviation 0.1956
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Direct Bilirubin
|
—
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.000
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.098
|
0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.050
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Creatinine
|
0.918 Milligram per deciliter (MG/DL)
Standard Deviation 0.2322
|
0.955 Milligram per deciliter (MG/DL)
Standard Deviation 0.0750
|
0.917 Milligram per deciliter (MG/DL)
Standard Deviation 0.1657
|
1.105 Milligram per deciliter (MG/DL)
Standard Deviation 0.3136
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Creatinine
|
0.008 Milligram per deciliter (MG/DL)
Standard Deviation 0.1121
|
-0.032 Milligram per deciliter (MG/DL)
Standard Deviation 0.0708
|
0.108 Milligram per deciliter (MG/DL)
Standard Deviation 0.1024
|
-0.007 Milligram per deciliter (MG/DL)
Standard Deviation 0.1371
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Creatinine
|
0.047 Milligram per deciliter (MG/DL)
Standard Deviation 0.0880
|
0.000 Milligram per deciliter (MG/DL)
Standard Deviation 0.1163
|
0.037 Milligram per deciliter (MG/DL)
Standard Deviation 0.0766
|
-0.013 Milligram per deciliter (MG/DL)
Standard Deviation 0.1317
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Creatinine
|
0.053 Milligram per deciliter (MG/DL)
Standard Deviation 0.0755
|
0.038 Milligram per deciliter (MG/DL)
Standard Deviation 0.1196
|
0.042 Milligram per deciliter (MG/DL)
Standard Deviation 0.0891
|
-0.038 Milligram per deciliter (MG/DL)
Standard Deviation 0.1512
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Calcium
|
-0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.361
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.356
|
0.08 Milligram per deciliter (MG/DL)
Standard Deviation 0.488
|
-0.26 Milligram per deciliter (MG/DL)
Standard Deviation 0.550
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Calcium
|
0.13 Milligram per deciliter (MG/DL)
Standard Deviation 0.367
|
-0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.378
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.472
|
-0.16 Milligram per deciliter (MG/DL)
Standard Deviation 0.498
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Calcium
|
-0.15 Milligram per deciliter (MG/DL)
Standard Deviation 0.638
|
-0.32 Milligram per deciliter (MG/DL)
Standard Deviation 0.306
|
-0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.327
|
-0.30 Milligram per deciliter (MG/DL)
Standard Deviation 0.660
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Creatinine
|
0.043 Milligram per deciliter (MG/DL)
Standard Deviation 0.1179
|
0.008 Milligram per deciliter (MG/DL)
Standard Deviation 0.0924
|
0.082 Milligram per deciliter (MG/DL)
Standard Deviation 0.1389
|
-0.024 Milligram per deciliter (MG/DL)
Standard Deviation 0.1747
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Calcium
|
0.12 Milligram per deciliter (MG/DL)
Standard Deviation 0.279
|
-0.27 Milligram per deciliter (MG/DL)
Standard Deviation 0.393
|
0.05 Milligram per deciliter (MG/DL)
Standard Deviation 0.509
|
-0.08 Milligram per deciliter (MG/DL)
Standard Deviation 0.512
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Calcium
|
—
|
-0.15 Milligram per deciliter (MG/DL)
Standard Deviation 0.446
|
0.23 Milligram per deciliter (MG/DL)
Standard Deviation 0.484
|
0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.377
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Creatinine
|
0.020 Milligram per deciliter (MG/DL)
Standard Deviation 0.1316
|
-0.045 Milligram per deciliter (MG/DL)
Standard Deviation 0.0922
|
0.113 Milligram per deciliter (MG/DL)
Standard Deviation 0.1088
|
-0.018 Milligram per deciliter (MG/DL)
Standard Deviation 0.2525
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Creatinine
|
-0.002 Milligram per deciliter (MG/DL)
Standard Deviation 0.1321
|
0.012 Milligram per deciliter (MG/DL)
Standard Deviation 0.1297
|
0.047 Milligram per deciliter (MG/DL)
Standard Deviation 0.1196
|
0.015 Milligram per deciliter (MG/DL)
Standard Deviation 0.2118
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Creatinine
|
—
|
0.008 Milligram per deciliter (MG/DL)
Standard Deviation 0.1072
|
0.092 Milligram per deciliter (MG/DL)
Standard Deviation 0.0909
|
-0.045 Milligram per deciliter (MG/DL)
Standard Deviation 0.3023
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Uric Acid
|
4.87 Milligram per deciliter (MG/DL)
Standard Deviation 1.172
|
5.97 Milligram per deciliter (MG/DL)
Standard Deviation 1.335
|
5.77 Milligram per deciliter (MG/DL)
Standard Deviation 1.039
|
5.58 Milligram per deciliter (MG/DL)
Standard Deviation 1.238
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Uric Acid
|
-0.05 Milligram per deciliter (MG/DL)
Standard Deviation 0.539
|
-0.25 Milligram per deciliter (MG/DL)
Standard Deviation 0.176
|
0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.640
|
0.22 Milligram per deciliter (MG/DL)
Standard Deviation 0.471
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Uric Acid
|
-0.05 Milligram per deciliter (MG/DL)
Standard Deviation 0.497
|
-0.25 Milligram per deciliter (MG/DL)
Standard Deviation 0.383
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.566
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.463
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Uric Acid
|
-0.08 Milligram per deciliter (MG/DL)
Standard Deviation 0.722
|
0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.327
|
-0.12 Milligram per deciliter (MG/DL)
Standard Deviation 0.943
|
-0.48 Milligram per deciliter (MG/DL)
Standard Deviation 0.487
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Uric Acid
|
-0.32 Milligram per deciliter (MG/DL)
Standard Deviation 0.571
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.694
|
0.32 Milligram per deciliter (MG/DL)
Standard Deviation 0.804
|
0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.997
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Bilirubin
|
0.48 Milligram per deciliter (MG/DL)
Standard Deviation 0.147
|
0.58 Milligram per deciliter (MG/DL)
Standard Deviation 0.422
|
0.47 Milligram per deciliter (MG/DL)
Standard Deviation 0.234
|
0.52 Milligram per deciliter (MG/DL)
Standard Deviation 0.204
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Uric Acid
|
-0.05 Milligram per deciliter (MG/DL)
Standard Deviation 0.641
|
-0.05 Milligram per deciliter (MG/DL)
Standard Deviation 0.701
|
0.18 Milligram per deciliter (MG/DL)
Standard Deviation 0.828
|
0.32 Milligram per deciliter (MG/DL)
Standard Deviation 0.785
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Bilirubin
|
-0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.141
|
-0.08 Milligram per deciliter (MG/DL)
Standard Deviation 0.325
|
0.20 Milligram per deciliter (MG/DL)
Standard Deviation 0.276
|
-0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.158
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Uric Acid
|
0.23 Milligram per deciliter (MG/DL)
Standard Deviation 0.855
|
-0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.698
|
0.28 Milligram per deciliter (MG/DL)
Standard Deviation 0.422
|
0.22 Milligram per deciliter (MG/DL)
Standard Deviation 0.779
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Bilirubin
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.082
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.343
|
0.20 Milligram per deciliter (MG/DL)
Standard Deviation 0.316
|
-0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.158
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Bilirubin
|
-0.05 Milligram per deciliter (MG/DL)
Standard Deviation 0.122
|
-0.12 Milligram per deciliter (MG/DL)
Standard Deviation 0.264
|
0.08 Milligram per deciliter (MG/DL)
Standard Deviation 0.435
|
-0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.126
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Bilirubin
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.133
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.121
|
0.25 Milligram per deciliter (MG/DL)
Standard Deviation 0.409
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.121
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Bilirubin
|
-0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.082
|
-0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.250
|
0.12 Milligram per deciliter (MG/DL)
Standard Deviation 0.133
|
-0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.122
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Calcium
|
9.62 Milligram per deciliter (MG/DL)
Standard Deviation 0.248
|
9.62 Milligram per deciliter (MG/DL)
Standard Deviation 0.458
|
9.60 Milligram per deciliter (MG/DL)
Standard Deviation 0.358
|
9.76 Milligram per deciliter (MG/DL)
Standard Deviation 0.301
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Calcium
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.335
|
-0.22 Milligram per deciliter (MG/DL)
Standard Deviation 0.264
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.395
|
-0.37 Milligram per deciliter (MG/DL)
Standard Deviation 0.301
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Calcium
|
0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.550
|
-0.07 Milligram per deciliter (MG/DL)
Standard Deviation 0.344
|
0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.540
|
-0.22 Milligram per deciliter (MG/DL)
Standard Deviation 0.471
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Calcium
|
0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.369
|
-0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.388
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.387
|
-0.38 Milligram per deciliter (MG/DL)
Standard Deviation 0.396
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Direct Bilirubin
|
0.15 Milligram per deciliter (MG/DL)
Standard Deviation 0.055
|
0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.082
|
0.15 Milligram per deciliter (MG/DL)
Standard Deviation 0.055
|
0.13 Milligram per deciliter (MG/DL)
Standard Deviation 0.052
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Phosphate
|
3.20 Milligram per deciliter (MG/DL)
Standard Deviation 0.583
|
3.48 Milligram per deciliter (MG/DL)
Standard Deviation 0.376
|
3.62 Milligram per deciliter (MG/DL)
Standard Deviation 0.637
|
3.28 Milligram per deciliter (MG/DL)
Standard Deviation 0.717
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Direct Bilirubin
|
-0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.052
|
-0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.052
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.082
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.041
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Direct Bilirubin
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.063
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.000
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.098
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.071
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Direct Bilirubin
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.063
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.041
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.063
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.000
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Phosphate
|
0.22 Milligram per deciliter (MG/DL)
Standard Deviation 0.417
|
0.08 Milligram per deciliter (MG/DL)
Standard Deviation 0.382
|
0.18 Milligram per deciliter (MG/DL)
Standard Deviation 0.310
|
0.22 Milligram per deciliter (MG/DL)
Standard Deviation 0.508
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Direct Bilirubin
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.075
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.041
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.071
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.045
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Direct Bilirubin
|
-0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.052
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.041
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.063
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.000
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Direct Bilirubin
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.041
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.041
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.098
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.045
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Direct Bilirubin
|
-0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.075
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.000
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.000
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.063
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Phosphate
|
-0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.273
|
0.02 Milligram per deciliter (MG/DL)
Standard Deviation 0.194
|
0.25 Milligram per deciliter (MG/DL)
Standard Deviation 0.539
|
0.22 Milligram per deciliter (MG/DL)
Standard Deviation 0.598
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Phosphate
|
0.27 Milligram per deciliter (MG/DL)
Standard Deviation 0.489
|
0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.197
|
0.12 Milligram per deciliter (MG/DL)
Standard Deviation 0.512
|
0.12 Milligram per deciliter (MG/DL)
Standard Deviation 0.466
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Phosphate
|
0.27 Milligram per deciliter (MG/DL)
Standard Deviation 0.308
|
0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.197
|
0.03 Milligram per deciliter (MG/DL)
Standard Deviation 0.356
|
0.38 Milligram per deciliter (MG/DL)
Standard Deviation 0.497
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Phosphate
|
0.32 Milligram per deciliter (MG/DL)
Standard Deviation 0.360
|
0.00 Milligram per deciliter (MG/DL)
Standard Deviation 0.369
|
-0.27 Milligram per deciliter (MG/DL)
Standard Deviation 0.575
|
0.58 Milligram per deciliter (MG/DL)
Standard Deviation 0.554
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Phosphate
|
0.17 Milligram per deciliter (MG/DL)
Standard Deviation 0.459
|
-0.12 Milligram per deciliter (MG/DL)
Standard Deviation 0.331
|
0.15 Milligram per deciliter (MG/DL)
Standard Deviation 0.418
|
0.36 Milligram per deciliter (MG/DL)
Standard Deviation 0.581
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Phosphate
|
0.13 Milligram per deciliter (MG/DL)
Standard Deviation 0.472
|
-0.10 Milligram per deciliter (MG/DL)
Standard Deviation 0.456
|
0.15 Milligram per deciliter (MG/DL)
Standard Deviation 0.521
|
0.30 Milligram per deciliter (MG/DL)
Standard Deviation 0.863
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Phosphate
|
—
|
0.25 Milligram per deciliter (MG/DL)
Standard Deviation 0.217
|
0.12 Milligram per deciliter (MG/DL)
Standard Deviation 0.598
|
0.15 Milligram per deciliter (MG/DL)
Standard Deviation 0.412
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Glucose
|
93.8 Milligram per deciliter (MG/DL)
Standard Deviation 11.20
|
92.5 Milligram per deciliter (MG/DL)
Standard Deviation 7.84
|
90.0 Milligram per deciliter (MG/DL)
Standard Deviation 13.97
|
95.8 Milligram per deciliter (MG/DL)
Standard Deviation 9.99
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Glucose
|
22.8 Milligram per deciliter (MG/DL)
Standard Deviation 48.16
|
3.8 Milligram per deciliter (MG/DL)
Standard Deviation 9.77
|
7.0 Milligram per deciliter (MG/DL)
Standard Deviation 5.48
|
3.3 Milligram per deciliter (MG/DL)
Standard Deviation 14.39
|
|
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Glucose
|
1.7 Milligram per deciliter (MG/DL)
Standard Deviation 6.19
|
3.7 Milligram per deciliter (MG/DL)
Standard Deviation 7.42
|
6.5 Milligram per deciliter (MG/DL)
Standard Deviation 15.67
|
0.5 Milligram per deciliter (MG/DL)
Standard Deviation 11.04
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Protein
|
7.07 Gram per deciliter (g/dL)
Standard Deviation 0.273
|
6.93 Gram per deciliter (g/dL)
Standard Deviation 0.273
|
6.97 Gram per deciliter (g/dL)
Standard Deviation 0.234
|
6.77 Gram per deciliter (g/dL)
Standard Deviation 0.225
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Protein
|
-0.25 Gram per deciliter (g/dL)
Standard Deviation 0.274
|
-0.25 Gram per deciliter (g/dL)
Standard Deviation 0.302
|
-0.23 Gram per deciliter (g/dL)
Standard Deviation 0.386
|
-0.15 Gram per deciliter (g/dL)
Standard Deviation 0.266
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Protein
|
-0.08 Gram per deciliter (g/dL)
Standard Deviation 0.392
|
-0.25 Gram per deciliter (g/dL)
Standard Deviation 0.207
|
-0.03 Gram per deciliter (g/dL)
Standard Deviation 0.266
|
-0.10 Gram per deciliter (g/dL)
Standard Deviation 0.434
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Protein
|
-0.03 Gram per deciliter (g/dL)
Standard Deviation 0.216
|
0.02 Gram per deciliter (g/dL)
Standard Deviation 0.293
|
0.02 Gram per deciliter (g/dL)
Standard Deviation 0.407
|
-0.06 Gram per deciliter (g/dL)
Standard Deviation 0.207
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Protein
|
-0.25 Gram per deciliter (g/dL)
Standard Deviation 0.339
|
-0.02 Gram per deciliter (g/dL)
Standard Deviation 0.343
|
-0.05 Gram per deciliter (g/dL)
Standard Deviation 0.383
|
-0.06 Gram per deciliter (g/dL)
Standard Deviation 0.378
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Protein
|
-0.28 Gram per deciliter (g/dL)
Standard Deviation 0.271
|
-0.17 Gram per deciliter (g/dL)
Standard Deviation 0.225
|
-0.05 Gram per deciliter (g/dL)
Standard Deviation 0.259
|
-0.36 Gram per deciliter (g/dL)
Standard Deviation 0.305
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Protein
|
-0.33 Gram per deciliter (g/dL)
Standard Deviation 0.273
|
-0.13 Gram per deciliter (g/dL)
Standard Deviation 0.250
|
-0.23 Gram per deciliter (g/dL)
Standard Deviation 0.207
|
0.00 Gram per deciliter (g/dL)
Standard Deviation 0.529
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Protein
|
-0.18 Gram per deciliter (g/dL)
Standard Deviation 0.354
|
-0.17 Gram per deciliter (g/dL)
Standard Deviation 0.383
|
0.03 Gram per deciliter (g/dL)
Standard Deviation 0.258
|
0.35 Gram per deciliter (g/dL)
Standard Deviation 0.404
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Protein
|
—
|
-0.03 Gram per deciliter (g/dL)
Standard Deviation 0.339
|
0.02 Gram per deciliter (g/dL)
Standard Deviation 0.319
|
0.10 Gram per deciliter (g/dL)
Standard Deviation 0.572
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Albumin
|
4.23 Gram per deciliter (g/dL)
Standard Deviation 0.301
|
4.48 Gram per deciliter (g/dL)
Standard Deviation 0.194
|
4.43 Gram per deciliter (g/dL)
Standard Deviation 0.121
|
4.28 Gram per deciliter (g/dL)
Standard Deviation 0.172
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Albumin
|
-0.10 Gram per deciliter (g/dL)
Standard Deviation 0.190
|
-0.12 Gram per deciliter (g/dL)
Standard Deviation 0.256
|
-0.13 Gram per deciliter (g/dL)
Standard Deviation 0.310
|
-0.03 Gram per deciliter (g/dL)
Standard Deviation 0.175
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Albumin
|
0.08 Gram per deciliter (g/dL)
Standard Deviation 0.319
|
-0.13 Gram per deciliter (g/dL)
Standard Deviation 0.151
|
0.02 Gram per deciliter (g/dL)
Standard Deviation 0.147
|
-0.12 Gram per deciliter (g/dL)
Standard Deviation 0.331
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Albumin
|
0.02 Gram per deciliter (g/dL)
Standard Deviation 0.098
|
-0.02 Gram per deciliter (g/dL)
Standard Deviation 0.286
|
0.02 Gram per deciliter (g/dL)
Standard Deviation 0.183
|
-0.06 Gram per deciliter (g/dL)
Standard Deviation 0.152
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Albumin
|
-0.12 Gram per deciliter (g/dL)
Standard Deviation 0.313
|
-0.07 Gram per deciliter (g/dL)
Standard Deviation 0.197
|
0.02 Gram per deciliter (g/dL)
Standard Deviation 0.117
|
-0.08 Gram per deciliter (g/dL)
Standard Deviation 0.277
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Albumin
|
-0.08 Gram per deciliter (g/dL)
Standard Deviation 0.133
|
-0.15 Gram per deciliter (g/dL)
Standard Deviation 0.152
|
0.02 Gram per deciliter (g/dL)
Standard Deviation 0.232
|
-0.14 Gram per deciliter (g/dL)
Standard Deviation 0.321
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Albumin
|
-0.17 Gram per deciliter (g/dL)
Standard Deviation 0.175
|
-0.10 Gram per deciliter (g/dL)
Standard Deviation 0.155
|
-0.08 Gram per deciliter (g/dL)
Standard Deviation 0.160
|
0.00 Gram per deciliter (g/dL)
Standard Deviation 0.354
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Albumin
|
0.03 Gram per deciliter (g/dL)
Standard Deviation 0.175
|
-0.05 Gram per deciliter (g/dL)
Standard Deviation 0.362
|
-0.02 Gram per deciliter (g/dL)
Standard Deviation 0.075
|
0.12 Gram per deciliter (g/dL)
Standard Deviation 0.256
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Albumin
|
—
|
-0.08 Gram per deciliter (g/dL)
Standard Deviation 0.264
|
0.00 Gram per deciliter (g/dL)
Standard Deviation 0.167
|
0.13 Gram per deciliter (g/dL)
Standard Deviation 0.377
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Hemoglobin
|
14.07 Gram per deciliter (g/dL)
Standard Deviation 1.392
|
14.28 Gram per deciliter (g/dL)
Standard Deviation 0.662
|
13.93 Gram per deciliter (g/dL)
Standard Deviation 1.007
|
13.80 Gram per deciliter (g/dL)
Standard Deviation 1.669
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Hemoglobin
|
-0.36 Gram per deciliter (g/dL)
Standard Deviation 0.493
|
-0.38 Gram per deciliter (g/dL)
Standard Deviation 0.337
|
-0.44 Gram per deciliter (g/dL)
Standard Deviation 1.029
|
-0.57 Gram per deciliter (g/dL)
Standard Deviation 0.468
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Hemoglobin
|
-0.03 Gram per deciliter (g/dL)
Standard Deviation 0.622
|
-0.68 Gram per deciliter (g/dL)
Standard Deviation 0.356
|
0.17 Gram per deciliter (g/dL)
Standard Deviation 0.308
|
-0.58 Gram per deciliter (g/dL)
Standard Deviation 0.960
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Hemoglobin
|
-0.28 Gram per deciliter (g/dL)
Standard Deviation 0.471
|
0.08 Gram per deciliter (g/dL)
Standard Deviation 0.576
|
0.18 Gram per deciliter (g/dL)
Standard Deviation 0.523
|
-0.75 Gram per deciliter (g/dL)
Standard Deviation 0.387
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Hemoglobin
|
-0.18 Gram per deciliter (g/dL)
Standard Deviation 0.627
|
-0.12 Gram per deciliter (g/dL)
Standard Deviation 0.714
|
-0.33 Gram per deciliter (g/dL)
Standard Deviation 0.905
|
-0.80 Gram per deciliter (g/dL)
Standard Deviation 0.592
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Hemoglobin
|
-0.48 Gram per deciliter (g/dL)
Standard Deviation 0.293
|
-0.10 Gram per deciliter (g/dL)
Standard Deviation 0.352
|
-0.25 Gram per deciliter (g/dL)
Standard Deviation 0.991
|
-0.66 Gram per deciliter (g/dL)
Standard Deviation 0.581
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Hemoglobin
|
-0.42 Gram per deciliter (g/dL)
Standard Deviation 0.462
|
-0.25 Gram per deciliter (g/dL)
Standard Deviation 0.451
|
-0.55 Gram per deciliter (g/dL)
Standard Deviation 0.819
|
-0.58 Gram per deciliter (g/dL)
Standard Deviation 0.507
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Hemoglobin
|
-0.12 Gram per deciliter (g/dL)
Standard Deviation 0.585
|
0.00 Gram per deciliter (g/dL)
Standard Deviation 0.525
|
0.15 Gram per deciliter (g/dL)
Standard Deviation 0.709
|
-0.12 Gram per deciliter (g/dL)
Standard Deviation 0.769
|
|
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Hemoglobin
|
—
|
0.28 Gram per deciliter (g/dL)
Standard Deviation 1.1136
|
0.05 Gram per deciliter (g/dL)
Standard Deviation 0.565
|
-0.55 Gram per deciliter (g/dL)
Standard Deviation 1.473
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Following parameters were analyzed for laboratory examination: Aspartate Aminotransferase (AMT), Creatine Kinase (CK), Alanine Aminotransferase (ALT), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD), Alkaline Phosphatase (AP).
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: CK
|
15.0 international units per liter (IU/L)
Standard Deviation 43.26
|
19.0 international units per liter (IU/L)
Standard Deviation 29.14
|
77.8 international units per liter (IU/L)
Standard Deviation 148.91
|
7.5 international units per liter (IU/L)
Standard Deviation 9.79
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: AST
|
22.2 international units per liter (IU/L)
Standard Deviation 3.13
|
21.2 international units per liter (IU/L)
Standard Deviation 1.60
|
25.5 international units per liter (IU/L)
Standard Deviation 11.38
|
19.5 international units per liter (IU/L)
Standard Deviation 4.55
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: ALT
|
17.0 international units per liter (IU/L)
Standard Deviation 4.00
|
19.5 international units per liter (IU/L)
Standard Deviation 1.64
|
24.3 international units per liter (IU/L)
Standard Deviation 14.14
|
17.2 international units per liter (IU/L)
Standard Deviation 5.27
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: AST
|
-1.2 international units per liter (IU/L)
Standard Deviation 8.16
|
-1.0 international units per liter (IU/L)
Standard Deviation 1.41
|
-6.8 international units per liter (IU/L)
Standard Deviation 12.26
|
-1.3 international units per liter (IU/L)
Standard Deviation 3.20
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: AST
|
1.3 international units per liter (IU/L)
Standard Deviation 3.93
|
0.0 international units per liter (IU/L)
Standard Deviation 0.89
|
-3.7 international units per liter (IU/L)
Standard Deviation 10.05
|
2.5 international units per liter (IU/L)
Standard Deviation 7.79
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: AST
|
-3.5 international units per liter (IU/L)
Standard Deviation 2.95
|
-0.2 international units per liter (IU/L)
Standard Deviation 2.48
|
-4.3 international units per liter (IU/L)
Standard Deviation 11.02
|
-0.8 international units per liter (IU/L)
Standard Deviation 3.86
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: AST
|
0.2 international units per liter (IU/L)
Standard Deviation 5.81
|
2.0 international units per liter (IU/L)
Standard Deviation 1.67
|
-5.8 international units per liter (IU/L)
Standard Deviation 11.61
|
-2.2 international units per liter (IU/L)
Standard Deviation 2.77
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: AST
|
-3.3 international units per liter (IU/L)
Standard Deviation 4.27
|
-0.5 international units per liter (IU/L)
Standard Deviation 2.35
|
-5.2 international units per liter (IU/L)
Standard Deviation 9.58
|
-1.0 international units per liter (IU/L)
Standard Deviation 4.64
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: AST
|
-3.2 international units per liter (IU/L)
Standard Deviation 2.64
|
-0.3 international units per liter (IU/L)
Standard Deviation 3.14
|
-6.2 international units per liter (IU/L)
Standard Deviation 9.26
|
0.6 international units per liter (IU/L)
Standard Deviation 3.65
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: AST
|
0.3 international units per liter (IU/L)
Standard Deviation 4.18
|
-0.7 international units per liter (IU/L)
Standard Deviation 4.27
|
-3.8 international units per liter (IU/L)
Standard Deviation 11.34
|
1.8 international units per liter (IU/L)
Standard Deviation 2.64
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: AST
|
—
|
-0.5 international units per liter (IU/L)
Standard Deviation 1.87
|
-3.8 international units per liter (IU/L)
Standard Deviation 9.77
|
7.5 international units per liter (IU/L)
Standard Deviation 10.47
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: CK
|
97.2 international units per liter (IU/L)
Standard Deviation 40.32
|
104.8 international units per liter (IU/L)
Standard Deviation 74.79
|
80.0 international units per liter (IU/L)
Standard Deviation 20.21
|
67.5 international units per liter (IU/L)
Standard Deviation 26.91
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: CK
|
-26.3 international units per liter (IU/L)
Standard Deviation 26.07
|
0.7 international units per liter (IU/L)
Standard Deviation 15.06
|
-7.3 international units per liter (IU/L)
Standard Deviation 24.10
|
9.2 international units per liter (IU/L)
Standard Deviation 18.69
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: CK
|
-0.5 international units per liter (IU/L)
Standard Deviation 79.89
|
-4.2 international units per liter (IU/L)
Standard Deviation 12.48
|
12.0 international units per liter (IU/L)
Standard Deviation 11.45
|
8.7 international units per liter (IU/L)
Standard Deviation 15.60
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: CK
|
-15.3 international units per liter (IU/L)
Standard Deviation 12.60
|
1.0 international units per liter (IU/L)
Standard Deviation 18.22
|
7.5 international units per liter (IU/L)
Standard Deviation 26.77
|
3.2 international units per liter (IU/L)
Standard Deviation 14.20
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: CK
|
-32.5 international units per liter (IU/L)
Standard Deviation 34.16
|
7.5 international units per liter (IU/L)
Standard Deviation 18.73
|
2.8 international units per liter (IU/L)
Standard Deviation 13.10
|
-2.0 international units per liter (IU/L)
Standard Deviation 19.79
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: CK
|
-16.7 international units per liter (IU/L)
Standard Deviation 28.79
|
7.7 international units per liter (IU/L)
Standard Deviation 19.71
|
0.5 international units per liter (IU/L)
Standard Deviation 29.92
|
53.0 international units per liter (IU/L)
Standard Deviation 106.50
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: CK
|
-29.3 international units per liter (IU/L)
Standard Deviation 24.47
|
16.3 international units per liter (IU/L)
Standard Deviation 45.35
|
21.7 international units per liter (IU/L)
Standard Deviation 59.27
|
8.8 international units per liter (IU/L)
Standard Deviation 16.16
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: CK
|
—
|
61.8 international units per liter (IU/L)
Standard Deviation 134.00
|
19.0 international units per liter (IU/L)
Standard Deviation 31.69
|
9.5 international units per liter (IU/L)
Standard Deviation 8.58
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: ALT
|
-0.3 international units per liter (IU/L)
Standard Deviation 5.13
|
0.3 international units per liter (IU/L)
Standard Deviation 2.66
|
-11.3 international units per liter (IU/L)
Standard Deviation 14.24
|
-0.2 international units per liter (IU/L)
Standard Deviation 0.98
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: ALT
|
1.8 international units per liter (IU/L)
Standard Deviation 3.54
|
0.8 international units per liter (IU/L)
Standard Deviation 1.60
|
-6.2 international units per liter (IU/L)
Standard Deviation 13.70
|
3.3 international units per liter (IU/L)
Standard Deviation 11.24
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: ALT
|
-1.8 international units per liter (IU/L)
Standard Deviation 4.07
|
-1.2 international units per liter (IU/L)
Standard Deviation 2.40
|
-6.8 international units per liter (IU/L)
Standard Deviation 14.13
|
-2.5 international units per liter (IU/L)
Standard Deviation 3.32
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: ALT
|
8.2 international units per liter (IU/L)
Standard Deviation 25.13
|
2.2 international units per liter (IU/L)
Standard Deviation 2.48
|
-7.2 international units per liter (IU/L)
Standard Deviation 14.50
|
-2.2 international units per liter (IU/L)
Standard Deviation 3.96
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: ALT
|
-3.0 international units per liter (IU/L)
Standard Deviation 4.15
|
-1.8 international units per liter (IU/L)
Standard Deviation 3.49
|
-6.5 international units per liter (IU/L)
Standard Deviation 10.54
|
-1.0 international units per liter (IU/L)
Standard Deviation 4.06
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: ALT
|
-2.0 international units per liter (IU/L)
Standard Deviation 4.52
|
-1.2 international units per liter (IU/L)
Standard Deviation 3.54
|
-8.7 international units per liter (IU/L)
Standard Deviation 13.81
|
0.8 international units per liter (IU/L)
Standard Deviation 4.55
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: ALT
|
1.0 international units per liter (IU/L)
Standard Deviation 3.69
|
-1.0 international units per liter (IU/L)
Standard Deviation 3.46
|
-6.7 international units per liter (IU/L)
Standard Deviation 13.28
|
0.3 international units per liter (IU/L)
Standard Deviation 3.44
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: ALT
|
—
|
0.3 international units per liter (IU/L)
Standard Deviation 1.97
|
-6.8 international units per liter (IU/L)
Standard Deviation 12.80
|
13.8 international units per liter (IU/L)
Standard Deviation 25.33
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: GGT
|
22.0 international units per liter (IU/L)
Standard Deviation 6.78
|
21.5 international units per liter (IU/L)
Standard Deviation 8.29
|
17.3 international units per liter (IU/L)
Standard Deviation 7.37
|
20.0 international units per liter (IU/L)
Standard Deviation 10.32
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: GGT
|
-2.7 international units per liter (IU/L)
Standard Deviation 2.58
|
-0.3 international units per liter (IU/L)
Standard Deviation 3.93
|
-1.8 international units per liter (IU/L)
Standard Deviation 2.06
|
-0.7 international units per liter (IU/L)
Standard Deviation 1.21
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: GGT
|
-2.3 international units per liter (IU/L)
Standard Deviation 3.39
|
-1.3 international units per liter (IU/L)
Standard Deviation 3.27
|
0.5 international units per liter (IU/L)
Standard Deviation 2.59
|
-0.8 international units per liter (IU/L)
Standard Deviation 1.17
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: GGT
|
-2.0 international units per liter (IU/L)
Standard Deviation 4.05
|
-0.7 international units per liter (IU/L)
Standard Deviation 2.34
|
-0.7 international units per liter (IU/L)
Standard Deviation 4.80
|
-2.0 international units per liter (IU/L)
Standard Deviation 4.12
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: GGT
|
-2.2 international units per liter (IU/L)
Standard Deviation 6.88
|
-0.8 international units per liter (IU/L)
Standard Deviation 4.75
|
-1.2 international units per liter (IU/L)
Standard Deviation 2.48
|
-1.0 international units per liter (IU/L)
Standard Deviation 3.39
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: GGT
|
-4.5 international units per liter (IU/L)
Standard Deviation 5.01
|
-2.2 international units per liter (IU/L)
Standard Deviation 4.71
|
-0.2 international units per liter (IU/L)
Standard Deviation 2.04
|
0.0 international units per liter (IU/L)
Standard Deviation 1.41
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: GGT
|
-5.0 international units per liter (IU/L)
Standard Deviation 4.52
|
-2.3 international units per liter (IU/L)
Standard Deviation 5.01
|
-1.3 international units per liter (IU/L)
Standard Deviation 2.73
|
0.8 international units per liter (IU/L)
Standard Deviation 1.92
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: GGT
|
-3.3 international units per liter (IU/L)
Standard Deviation 3.33
|
-1.5 international units per liter (IU/L)
Standard Deviation 3.39
|
0.2 international units per liter (IU/L)
Standard Deviation 2.56
|
1.3 international units per liter (IU/L)
Standard Deviation 3.98
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: GGT
|
—
|
-2.3 international units per liter (IU/L)
Standard Deviation 4.32
|
0.5 international units per liter (IU/L)
Standard Deviation 1.97
|
31.5 international units per liter (IU/L)
Standard Deviation 61.07
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: LD
|
174.5 international units per liter (IU/L)
Standard Deviation 13.40
|
174.7 international units per liter (IU/L)
Standard Deviation 25.11
|
166.7 international units per liter (IU/L)
Standard Deviation 19.65
|
172.0 international units per liter (IU/L)
Standard Deviation 20.03
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: LD
|
-15.7 international units per liter (IU/L)
Standard Deviation 13.06
|
-14.5 international units per liter (IU/L)
Standard Deviation 9.89
|
-8.0 international units per liter (IU/L)
Standard Deviation 15.47
|
-4.3 international units per liter (IU/L)
Standard Deviation 20.26
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: LD
|
-3.0 international units per liter (IU/L)
Standard Deviation 30.42
|
-10.0 international units per liter (IU/L)
Standard Deviation 7.69
|
-1.2 international units per liter (IU/L)
Standard Deviation 13.51
|
1.2 international units per liter (IU/L)
Standard Deviation 8.53
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: LD
|
-11.3 international units per liter (IU/L)
Standard Deviation 9.40
|
-3.5 international units per liter (IU/L)
Standard Deviation 17.93
|
-1.7 international units per liter (IU/L)
Standard Deviation 13.69
|
3.3 international units per liter (IU/L)
Standard Deviation 25.53
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: LD
|
-18.0 international units per liter (IU/L)
Standard Deviation 6.90
|
0.0 international units per liter (IU/L)
Standard Deviation 17.42
|
-0.8 international units per liter (IU/L)
Standard Deviation 12.72
|
-6.0 international units per liter (IU/L)
Standard Deviation 15.87
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: LD
|
-17.3 international units per liter (IU/L)
Standard Deviation 9.65
|
-14.0 international units per liter (IU/L)
Standard Deviation 21.95
|
-1.0 international units per liter (IU/L)
Standard Deviation 15.48
|
-1.2 international units per liter (IU/L)
Standard Deviation 16.57
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: LD
|
-7.5 international units per liter (IU/L)
Standard Deviation 18.56
|
-6.5 international units per liter (IU/L)
Standard Deviation 17.56
|
-2.8 international units per liter (IU/L)
Standard Deviation 13.51
|
0.2 international units per liter (IU/L)
Standard Deviation 18.35
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: LD
|
5.7 international units per liter (IU/L)
Standard Deviation 27.16
|
-6.0 international units per liter (IU/L)
Standard Deviation 13.11
|
4.8 international units per liter (IU/L)
Standard Deviation 18.63
|
-4.0 international units per liter (IU/L)
Standard Deviation 18.61
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: LD
|
—
|
-5.2 international units per liter (IU/L)
Standard Deviation 15.56
|
7.2 international units per liter (IU/L)
Standard Deviation 19.22
|
-6.5 international units per liter (IU/L)
Standard Deviation 38.66
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: AP
|
63.5 international units per liter (IU/L)
Standard Deviation 20.34
|
72.5 international units per liter (IU/L)
Standard Deviation 22.65
|
59.3 international units per liter (IU/L)
Standard Deviation 12.72
|
69.7 international units per liter (IU/L)
Standard Deviation 9.73
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: AP
|
-1.3 international units per liter (IU/L)
Standard Deviation 3.72
|
-4.0 international units per liter (IU/L)
Standard Deviation 4.43
|
-6.8 international units per liter (IU/L)
Standard Deviation 2.50
|
-1.7 international units per liter (IU/L)
Standard Deviation 3.78
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: AP
|
-2.3 international units per liter (IU/L)
Standard Deviation 6.56
|
-4.7 international units per liter (IU/L)
Standard Deviation 3.98
|
-5.3 international units per liter (IU/L)
Standard Deviation 9.87
|
-0.8 international units per liter (IU/L)
Standard Deviation 3.31
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: AP
|
-2.3 international units per liter (IU/L)
Standard Deviation 8.62
|
-0.8 international units per liter (IU/L)
Standard Deviation 6.31
|
-7.7 international units per liter (IU/L)
Standard Deviation 9.67
|
0.2 international units per liter (IU/L)
Standard Deviation 5.89
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: AP
|
-1.7 international units per liter (IU/L)
Standard Deviation 7.17
|
-0.5 international units per liter (IU/L)
Standard Deviation 10.84
|
-6.5 international units per liter (IU/L)
Standard Deviation 8.24
|
5.8 international units per liter (IU/L)
Standard Deviation 5.12
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: AP
|
-1.0 international units per liter (IU/L)
Standard Deviation 12.12
|
-6.5 international units per liter (IU/L)
Standard Deviation 10.80
|
-6.5 international units per liter (IU/L)
Standard Deviation 8.98
|
1.4 international units per liter (IU/L)
Standard Deviation 4.51
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: AP
|
-1.3 international units per liter (IU/L)
Standard Deviation 8.36
|
-4.2 international units per liter (IU/L)
Standard Deviation 10.61
|
-5.8 international units per liter (IU/L)
Standard Deviation 11.25
|
3.4 international units per liter (IU/L)
Standard Deviation 5.55
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: AP
|
3.3 international units per liter (IU/L)
Standard Deviation 9.95
|
-6.0 international units per liter (IU/L)
Standard Deviation 9.32
|
-6.2 international units per liter (IU/L)
Standard Deviation 10.94
|
8.8 international units per liter (IU/L)
Standard Deviation 9.45
|
|
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: AP
|
—
|
-5.8 international units per liter (IU/L)
Standard Deviation 14.80
|
-3.3 international units per liter (IU/L)
Standard Deviation 11.52
|
9.3 international units per liter (IU/L)
Standard Deviation 18.71
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Magnesium
|
-0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.082
|
-0.05 Milliequivalent per liter (mEq/L)
Standard Deviation 0.138
|
-0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.133
|
0.00 Milliequivalent per liter (mEq/L)
Standard Deviation 0.063
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Chloride
|
-1.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.48
|
0.8 Milliequivalent per liter (mEq/L)
Standard Deviation 2.14
|
2.0 Milliequivalent per liter (mEq/L)
Standard Deviation 3.03
|
0.6 Milliequivalent per liter (mEq/L)
Standard Deviation 2.41
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Chloride
|
-1.3 Milliequivalent per liter (mEq/L)
Standard Deviation 3.72
|
0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.25
|
1.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.73
|
0.8 Milliequivalent per liter (mEq/L)
Standard Deviation 2.39
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Bicarbonate
|
—
|
0.2 Milliequivalent per liter (mEq/L)
Standard Deviation 3.06
|
-1.5 Milliequivalent per liter (mEq/L)
Standard Deviation 1.64
|
-1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.94
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Chloride
|
-1.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.88
|
-0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 1.37
|
0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 1.75
|
-0.2 Milliequivalent per liter (mEq/L)
Standard Deviation 3.11
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Chloride
|
-0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 3.83
|
1.7 Milliequivalent per liter (mEq/L)
Standard Deviation 3.50
|
1.3 Milliequivalent per liter (mEq/L)
Standard Deviation 1.03
|
-0.6 Milliequivalent per liter (mEq/L)
Standard Deviation 1.82
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Chloride
|
-0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 2.94
|
1.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.34
|
0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 1.86
|
-1.8 Milliequivalent per liter (mEq/L)
Standard Deviation 3.54
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Chloride
|
—
|
1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 1.79
|
0.5 Milliequivalent per liter (mEq/L)
Standard Deviation 3.21
|
-0.8 Milliequivalent per liter (mEq/L)
Standard Deviation 2.99
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Bicarbonate
|
27.0 Milliequivalent per liter (mEq/L)
Standard Deviation 1.55
|
27.3 Milliequivalent per liter (mEq/L)
Standard Deviation 1.03
|
26.5 Milliequivalent per liter (mEq/L)
Standard Deviation 2.43
|
28.0 Milliequivalent per liter (mEq/L)
Standard Deviation 1.67
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Bicarbonate
|
0.5 Milliequivalent per liter (mEq/L)
Standard Deviation 2.17
|
-0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 1.51
|
-1.8 Milliequivalent per liter (mEq/L)
Standard Deviation 4.15
|
-1.5 Milliequivalent per liter (mEq/L)
Standard Deviation 2.26
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Bicarbonate
|
1.5 Milliequivalent per liter (mEq/L)
Standard Deviation 1.76
|
-0.8 Milliequivalent per liter (mEq/L)
Standard Deviation 1.47
|
-0.5 Milliequivalent per liter (mEq/L)
Standard Deviation 1.87
|
-2.8 Milliequivalent per liter (mEq/L)
Standard Deviation 4.12
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Bicarbonate
|
0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.34
|
-0.5 Milliequivalent per liter (mEq/L)
Standard Deviation 1.87
|
-1.5 Milliequivalent per liter (mEq/L)
Standard Deviation 3.51
|
-2.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.92
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Bicarbonate
|
1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.53
|
-1.5 Milliequivalent per liter (mEq/L)
Standard Deviation 0.84
|
-0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 1.97
|
-1.6 Milliequivalent per liter (mEq/L)
Standard Deviation 3.51
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Bicarbonate
|
0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 2.94
|
-0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 1.21
|
-0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.42
|
-1.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.17
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Magnesium
|
1.72 Milliequivalent per liter (mEq/L)
Standard Deviation 0.075
|
1.88 Milliequivalent per liter (mEq/L)
Standard Deviation 0.160
|
1.67 Milliequivalent per liter (mEq/L)
Standard Deviation 0.294
|
1.83 Milliequivalent per liter (mEq/L)
Standard Deviation 0.052
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Bicarbonate
|
-0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 2.07
|
-1.5 Milliequivalent per liter (mEq/L)
Standard Deviation 2.07
|
-1.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.04
|
-1.4 Milliequivalent per liter (mEq/L)
Standard Deviation 2.07
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Bicarbonate
|
0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.16
|
-1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.19
|
0.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.23
|
-0.8 Milliequivalent per liter (mEq/L)
Standard Deviation 3.43
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Magnesium
|
0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.052
|
-0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.103
|
-0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.126
|
-0.10 Milliequivalent per liter (mEq/L)
Standard Deviation 0.000
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Magnesium
|
0.00 Milliequivalent per liter (mEq/L)
Standard Deviation 0.089
|
0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.151
|
0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.082
|
0.00 Milliequivalent per liter (mEq/L)
Standard Deviation 0.122
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Magnesium
|
0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.075
|
0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.160
|
0.05 Milliequivalent per liter (mEq/L)
Standard Deviation 0.084
|
-0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.084
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Magnesium
|
0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.075
|
-0.05 Milliequivalent per liter (mEq/L)
Standard Deviation 0.176
|
-0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.082
|
-0.06 Milliequivalent per liter (mEq/L)
Standard Deviation 0.055
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Magnesium
|
-0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.098
|
0.00 Milliequivalent per liter (mEq/L)
Standard Deviation 0.200
|
-0.05 Milliequivalent per liter (mEq/L)
Standard Deviation 0.055
|
-0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.130
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Magnesium
|
-0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.098
|
0.00 Milliequivalent per liter (mEq/L)
Standard Deviation 0.126
|
-0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.103
|
-0.07 Milliequivalent per liter (mEq/L)
Standard Deviation 0.121
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Magnesium
|
—
|
-0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.147
|
0.00 Milliequivalent per liter (mEq/L)
Standard Deviation 0.089
|
-0.10 Milliequivalent per liter (mEq/L)
Standard Deviation 0.183
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Potassium
|
4.52 Milliequivalent per liter (mEq/L)
Standard Deviation 0.204
|
4.40 Milliequivalent per liter (mEq/L)
Standard Deviation 0.200
|
4.22 Milliequivalent per liter (mEq/L)
Standard Deviation 0.475
|
4.42 Milliequivalent per liter (mEq/L)
Standard Deviation 0.354
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Sodium
|
140.0 Milliequivalent per liter (mEq/L)
Standard Deviation 1.26
|
137.8 Milliequivalent per liter (mEq/L)
Standard Deviation 5.88
|
140.0 Milliequivalent per liter (mEq/L)
Standard Deviation 1.79
|
141.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.07
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Sodium
|
-2.3 Milliequivalent per liter (mEq/L)
Standard Deviation 3.27
|
-0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 4.46
|
0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 0.96
|
-1.8 Milliequivalent per liter (mEq/L)
Standard Deviation 3.43
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Sodium
|
-0.3 Milliequivalent per liter (mEq/L)
Standard Deviation 2.80
|
0.5 Milliequivalent per liter (mEq/L)
Standard Deviation 4.97
|
0.5 Milliequivalent per liter (mEq/L)
Standard Deviation 2.17
|
0.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.97
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Sodium
|
-0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 3.01
|
1.3 Milliequivalent per liter (mEq/L)
Standard Deviation 3.01
|
0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 3.33
|
1.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.28
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Sodium
|
-0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 3.20
|
1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 3.41
|
0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 3.39
|
1.6 Milliequivalent per liter (mEq/L)
Standard Deviation 3.13
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Sodium
|
0.0 Milliequivalent per liter (mEq/L)
Standard Deviation 1.67
|
0.0 Milliequivalent per liter (mEq/L)
Standard Deviation 1.41
|
2.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.45
|
1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.55
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Sodium
|
-1.3 Milliequivalent per liter (mEq/L)
Standard Deviation 4.08
|
0.5 Milliequivalent per liter (mEq/L)
Standard Deviation 4.14
|
3.5 Milliequivalent per liter (mEq/L)
Standard Deviation 1.38
|
0.6 Milliequivalent per liter (mEq/L)
Standard Deviation 3.05
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Sodium
|
0.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.40
|
1.5 Milliequivalent per liter (mEq/L)
Standard Deviation 3.83
|
2.5 Milliequivalent per liter (mEq/L)
Standard Deviation 2.07
|
-0.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.48
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Sodium
|
—
|
1.5 Milliequivalent per liter (mEq/L)
Standard Deviation 3.15
|
2.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.32
|
1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.45
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Potassium
|
-0.18 Milliequivalent per liter (mEq/L)
Standard Deviation 0.183
|
-0.07 Milliequivalent per liter (mEq/L)
Standard Deviation 0.266
|
-0.08 Milliequivalent per liter (mEq/L)
Standard Deviation 0.15
|
-0.23 Milliequivalent per liter (mEq/L)
Standard Deviation 0.427
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Potassium
|
-0.18 Milliequivalent per liter (mEq/L)
Standard Deviation 0.223
|
-0.07 Milliequivalent per liter (mEq/L)
Standard Deviation 0.266
|
-0.12 Milliequivalent per liter (mEq/L)
Standard Deviation 0.504
|
-0.13 Milliequivalent per liter (mEq/L)
Standard Deviation 0.367
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Potassium
|
-0.28 Milliequivalent per liter (mEq/L)
Standard Deviation 0.248
|
0.08 Milliequivalent per liter (mEq/L)
Standard Deviation 0.248
|
0.10 Milliequivalent per liter (mEq/L)
Standard Deviation 0.438
|
-0.16 Milliequivalent per liter (mEq/L)
Standard Deviation 0.439
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Potassium
|
-0.10 Milliequivalent per liter (mEq/L)
Standard Deviation 0.322
|
0.10 Milliequivalent per liter (mEq/L)
Standard Deviation 0.303
|
0.00 Milliequivalent per liter (mEq/L)
Standard Deviation 0.490
|
0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.593
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Potassium
|
-0.20 Milliequivalent per liter (mEq/L)
Standard Deviation 0.253
|
0.08 Milliequivalent per liter (mEq/L)
Standard Deviation 0.160
|
-0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.535
|
0.02 Milliequivalent per liter (mEq/L)
Standard Deviation 0.536
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Potassium
|
0.03 Milliequivalent per liter (mEq/L)
Standard Deviation 0.121
|
-0.05 Milliequivalent per liter (mEq/L)
Standard Deviation 0.468
|
0.08 Milliequivalent per liter (mEq/L)
Standard Deviation 0.467
|
-0.04 Milliequivalent per liter (mEq/L)
Standard Deviation 0.586
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Potassium
|
-0.20 Milliequivalent per liter (mEq/L)
Standard Deviation 0.276
|
0.15 Milliequivalent per liter (mEq/L)
Standard Deviation 0.394
|
0.20 Milliequivalent per liter (mEq/L)
Standard Deviation 0.329
|
-0.13 Milliequivalent per liter (mEq/L)
Standard Deviation 0.484
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Potassium
|
—
|
0.40 Milliequivalent per liter (mEq/L)
Standard Deviation 0.369
|
0.38 Milliequivalent per liter (mEq/L)
Standard Deviation 0.458
|
-0.25 Milliequivalent per liter (mEq/L)
Standard Deviation 0.173
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Chloride
|
103.8 Milliequivalent per liter (mEq/L)
Standard Deviation 2.48
|
100.8 Milliequivalent per liter (mEq/L)
Standard Deviation 4.88
|
102.5 Milliequivalent per liter (mEq/L)
Standard Deviation 2.66
|
104.8 Milliequivalent per liter (mEq/L)
Standard Deviation 2.48
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Chloride
|
-1.8 Milliequivalent per liter (mEq/L)
Standard Deviation 2.79
|
0.7 Milliequivalent per liter (mEq/L)
Standard Deviation 2.66
|
1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.71
|
-1.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.40
|
|
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Chloride
|
-0.8 Milliequivalent per liter (mEq/L)
Standard Deviation 2.40
|
1.0 Milliequivalent per liter (mEq/L)
Standard Deviation 2.76
|
0.5 Milliequivalent per liter (mEq/L)
Standard Deviation 2.17
|
0.2 Milliequivalent per liter (mEq/L)
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Following hematology parameters were analyzed for laboratory examination: Hemoglobin, Hematocrit, Red blood cell (RBC) count, Platelet count, WBC count, Total neutrophils (Abs),Eosinophils (Abs),Monocytes (Abs),Basophils (Abs), Lymphocytes (Abs).
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Hematocrit
|
41.70 Percentage of RBCs to total blood volume
Standard Deviation 3.906
|
41.28 Percentage of RBCs to total blood volume
Standard Deviation 2.436
|
40.78 Percentage of RBCs to total blood volume
Standard Deviation 2.927
|
40.87 Percentage of RBCs to total blood volume
Standard Deviation 5.369
|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Hematocrit
|
-1.18 Percentage of RBCs to total blood volume
Standard Deviation 1.161
|
-0.67 Percentage of RBCs to total blood volume
Standard Deviation 0.864
|
-1.28 Percentage of RBCs to total blood volume
Standard Deviation 3.342
|
-1.73 Percentage of RBCs to total blood volume
Standard Deviation 1.866
|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Hematocrit
|
-0.25 Percentage of RBCs to total blood volume
Standard Deviation 1.545
|
-1.68 Percentage of RBCs to total blood volume
Standard Deviation 0.823
|
0.90 Percentage of RBCs to total blood volume
Standard Deviation 0.876
|
-1.35 Percentage of RBCs to total blood volume
Standard Deviation 2.914
|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Hematocrit
|
-0.53 Percentage of RBCs to total blood volume
Standard Deviation 1.458
|
0.56 Percentage of RBCs to total blood volume
Standard Deviation 1.593
|
1.25 Percentage of RBCs to total blood volume
Standard Deviation 1.714
|
-1.85 Percentage of RBCs to total blood volume
Standard Deviation 1.771
|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Hematocrit
|
0.07 Percentage of RBCs to total blood volume
Standard Deviation 2.272
|
0.08 Percentage of RBCs to total blood volume
Standard Deviation 2.464
|
-0.34 Percentage of RBCs to total blood volume
Standard Deviation 3.140
|
-2.18 Percentage of RBCs to total blood volume
Standard Deviation 1.847
|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Hematocrit
|
-0.60 Percentage of RBCs to total blood volume
Standard Deviation 1.797
|
0.53 Percentage of RBCs to total blood volume
Standard Deviation 1.280
|
-0.78 Percentage of RBCs to total blood volume
Standard Deviation 2.920
|
-1.30 Percentage of RBCs to total blood volume
Standard Deviation 1.687
|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Hematocrit
|
-1.47 Percentage of RBCs to total blood volume
Standard Deviation 1.480
|
0.05 Percentage of RBCs to total blood volume
Standard Deviation 1.294
|
-1.20 Percentage of RBCs to total blood volume
Standard Deviation 3.251
|
-1.26 Percentage of RBCs to total blood volume
Standard Deviation 0.730
|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Hematocrit
|
-0.30 Percentage of RBCs to total blood volume
Standard Deviation 1.611
|
1.50 Percentage of RBCs to total blood volume
Standard Deviation 1.745
|
1.15 Percentage of RBCs to total blood volume
Standard Deviation 2.393
|
0.22 Percentage of RBCs to total blood volume
Standard Deviation 2.845
|
|
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Hematocrit
|
—
|
2.07 Percentage of RBCs to total blood volume
Standard Deviation 3.841
|
0.23 Percentage of RBCs to total blood volume
Standard Deviation 2.007
|
-1.10 Percentage of RBCs to total blood volume
Standard Deviation 5.412
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: RBC
|
4.45 10^6 cells/microliter
Standard Deviation 0.394
|
4.48 10^6 cells/microliter
Standard Deviation 0.407
|
4.42 10^6 cells/microliter
Standard Deviation 0.417
|
4.43 10^6 cells/microliter
Standard Deviation 0.677
|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: RBC
|
-0.10 10^6 cells/microliter
Standard Deviation 0.141
|
-0.07 10^6 cells/microliter
Standard Deviation 0.103
|
-0.14 10^6 cells/microliter
Standard Deviation 0.358
|
-0.15 10^6 cells/microliter
Standard Deviation 0.176
|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: RBC
|
0.02 10^6 cells/microliter
Standard Deviation 0.160
|
-0.18 10^6 cells/microliter
Standard Deviation 0.110
|
0.02 10^6 cells/microliter
Standard Deviation 0.098
|
-0.10 10^6 cells/microliter
Standard Deviation 0.335
|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: RBC
|
-0.03 10^6 cells/microliter
Standard Deviation 0.151
|
0.00 10^6 cells/microliter
Standard Deviation 0.255
|
0.07 10^6 cells/microliter
Standard Deviation 0.121
|
-0.23 10^6 cells/microliter
Standard Deviation 0.126
|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: RBC
|
0.03 10^6 cells/microliter
Standard Deviation 0.207
|
-0.05 10^6 cells/microliter
Standard Deviation 0.302
|
-0.13 10^6 cells/microliter
Standard Deviation 0.242
|
-0.22 10^6 cells/microliter
Standard Deviation 0.277
|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: RBC
|
-0.07 10^6 cells/microliter
Standard Deviation 0.207
|
-0.03 10^6 cells/microliter
Standard Deviation 0.207
|
-0.13 10^6 cells/microliter
Standard Deviation 0.333
|
-0.08 10^6 cells/microliter
Standard Deviation 0.277
|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: RBC
|
-0.12 10^6 cells/microliter
Standard Deviation 0.172
|
-0.03 10^6 cells/microliter
Standard Deviation 0.163
|
-0.22 10^6 cells/microliter
Standard Deviation 0.319
|
-0.10 10^6 cells/microliter
Standard Deviation 0.187
|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: RBC
|
-0.02 10^6 cells/microliter
Standard Deviation 0.160
|
0.10 10^6 cells/microliter
Standard Deviation 0.110
|
0.03 10^6 cells/microliter
Standard Deviation 0.320
|
0.00 10^6 cells/microliter
Standard Deviation 0.292
|
|
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: RBC
|
—
|
0.15 10^6 cells/microliter
Standard Deviation 0.442
|
-0.02 10^6 cells/microliter
Standard Deviation 0.214
|
-0.23 10^6 cells/microliter
Standard Deviation 0.443
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Monocytes (abs)
|
-0.040 10^3 cells/microliter
Standard Deviation 0.1185
|
-0.022 10^3 cells/microliter
Standard Deviation 0.0991
|
-0.102 10^3 cells/microliter
Standard Deviation 0.0700
|
-0.100 10^3 cells/microliter
Standard Deviation 0.0702
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Neutrophils (abs)
|
0.154 10^3 cells/microliter
Standard Deviation 0.8442
|
-0.320 10^3 cells/microliter
Standard Deviation 0.7102
|
-0.264 10^3 cells/microliter
Standard Deviation 0.4348
|
-0.730 10^3 cells/microliter
Standard Deviation 1.9961
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Platelets
|
187.5 10^3 cells/microliter
Standard Deviation 50.91
|
209.3 10^3 cells/microliter
Standard Deviation 39.52
|
198.7 10^3 cells/microliter
Standard Deviation 57.30
|
204.2 10^3 cells/microliter
Standard Deviation 51.86
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Platelets
|
1.2 10^3 cells/microliter
Standard Deviation 13.55
|
-10.7 10^3 cells/microliter
Standard Deviation 21.99
|
-7.0 10^3 cells/microliter
Standard Deviation 22.30
|
0.7 10^3 cells/microliter
Standard Deviation 17.19
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Platelets
|
-1.0 10^3 cells/microliter
Standard Deviation 15.38
|
-14.4 10^3 cells/microliter
Standard Deviation 24.27
|
9.3 10^3 cells/microliter
Standard Deviation 14.49
|
-3.2 10^3 cells/microliter
Standard Deviation 18.85
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Platelets
|
-0.6 10^3 cells/microliter
Standard Deviation 14.17
|
4.0 10^3 cells/microliter
Standard Deviation 22.90
|
-1.0 10^3 cells/microliter
Standard Deviation 11.54
|
9.8 10^3 cells/microliter
Standard Deviation 31.96
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Platelets
|
13.5 10^3 cells/microliter
Standard Deviation 21.19
|
-3.5 10^3 cells/microliter
Standard Deviation 31.05
|
27.3 10^3 cells/microliter
Standard Deviation 55.97
|
10.4 10^3 cells/microliter
Standard Deviation 29.95
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Platelets
|
5.2 10^3 cells/microliter
Standard Deviation 20.97
|
-12.2 10^3 cells/microliter
Standard Deviation 16.80
|
-2.7 10^3 cells/microliter
Standard Deviation 41.86
|
-2.0 10^3 cells/microliter
Standard Deviation 17.72
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Platelets
|
4.5 10^3 cells/microliter
Standard Deviation 26.16
|
-1.2 10^3 cells/microliter
Standard Deviation 28.49
|
5.2 10^3 cells/microliter
Standard Deviation 13.52
|
-2.0 10^3 cells/microliter
Standard Deviation 35.94
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Platelets
|
5.4 10^3 cells/microliter
Standard Deviation 9.56
|
-5.5 10^3 cells/microliter
Standard Deviation 27.29
|
19.3 10^3 cells/microliter
Standard Deviation 30.32
|
0.2 10^3 cells/microliter
Standard Deviation 24.77
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Platelets
|
—
|
-11.8 10^3 cells/microliter
Standard Deviation 30.33
|
15.5 10^3 cells/microliter
Standard Deviation 16.36
|
6.0 10^3 cells/microliter
Standard Deviation 37.05
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: WBC
|
5.75 10^3 cells/microliter
Standard Deviation 1.744
|
6.08 10^3 cells/microliter
Standard Deviation 1.023
|
6.17 10^3 cells/microliter
Standard Deviation 1.334
|
7.40 10^3 cells/microliter
Standard Deviation 2.497
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: WBC
|
-0.02 10^3 cells/microliter
Standard Deviation 1.163
|
-0.40 10^3 cells/microliter
Standard Deviation 0.839
|
-0.54 10^3 cells/microliter
Standard Deviation 0.783
|
-1.02 10^3 cells/microliter
Standard Deviation 1.880
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: WBC
|
0.15 10^3 cells/microliter
Standard Deviation 1.104
|
-0.42 10^3 cells/microliter
Standard Deviation 0.676
|
-0.07 10^3 cells/microliter
Standard Deviation 0.579
|
-1.75 10^3 cells/microliter
Standard Deviation 1.260
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: WBC
|
0.30 10^3 cells/microliter
Standard Deviation 1.410
|
-0.28 10^3 cells/microliter
Standard Deviation 1.326
|
-0.33 10^3 cells/microliter
Standard Deviation 0.463
|
-1.08 10^3 cells/microliter
Standard Deviation 1.721
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: WBC
|
0.05 10^3 cells/microliter
Standard Deviation 1.048
|
0.32 10^3 cells/microliter
Standard Deviation 1.341
|
-0.35 10^3 cells/microliter
Standard Deviation 1.417
|
-0.76 10^3 cells/microliter
Standard Deviation 1.408
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: WBC
|
-0.33 10^3 cells/microliter
Standard Deviation 1.414
|
0.03 10^3 cells/microliter
Standard Deviation 1.166
|
-0.87 10^3 cells/microliter
Standard Deviation 1.571
|
-1.06 10^3 cells/microliter
Standard Deviation 1.324
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: WBC
|
-0.08 10^3 cells/microliter
Standard Deviation 1.280
|
-0.13 10^3 cells/microliter
Standard Deviation 1.657
|
-0.82 10^3 cells/microliter
Standard Deviation 0.454
|
-0.16 10^3 cells/microliter
Standard Deviation 1.766
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: WBC
|
0.35 10^3 cells/microliter
Standard Deviation 1.693
|
-0.42 10^3 cells/microliter
Standard Deviation 0.882
|
-0.10 10^3 cells/microliter
Standard Deviation 0.395
|
-0.82 10^3 cells/microliter
Standard Deviation 1.329
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: WBC
|
—
|
-0.18 10^3 cells/microliter
Standard Deviation 1.743
|
0.60 10^3 cells/microliter
Standard Deviation 2.199
|
-0.98 10^3 cells/microliter
Standard Deviation 1.513
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Neutrophils (abs)
|
3.508 10^3 cells/microliter
Standard Deviation 1.4359
|
3.813 10^3 cells/microliter
Standard Deviation 1.1002
|
3.637 10^3 cells/microliter
Standard Deviation 0.8430
|
5.077 10^3 cells/microliter
Standard Deviation 2.3807
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Neutrophils (abs)
|
0.237 10^3 cells/microliter
Standard Deviation 1.1972
|
-0.226 10^3 cells/microliter
Standard Deviation 0.7418
|
-0.007 10^3 cells/microliter
Standard Deviation 0.4337
|
-1.342 10^3 cells/microliter
Standard Deviation 1.2706
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Neutrophils (abs)
|
0.405 10^3 cells/microliter
Standard Deviation 1.3205
|
-0.062 10^3 cells/microliter
Standard Deviation 0.9878
|
-0.100 10^3 cells/microliter
Standard Deviation 0.3685
|
-0.925 10^3 cells/microliter
Standard Deviation 1.7647
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Neutrophils (abs)
|
0.043 10^3 cells/microliter
Standard Deviation 0.8887
|
0.455 10^3 cells/microliter
Standard Deviation 1.2804
|
0.218 10^3 cells/microliter
Standard Deviation 1.3491
|
-0.502 10^3 cells/microliter
Standard Deviation 1.5264
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Neutrophils (abs)
|
-0.348 10^3 cells/microliter
Standard Deviation 1.1549
|
0.260 10^3 cells/microliter
Standard Deviation 1.1844
|
-0.313 10^3 cells/microliter
Standard Deviation 1.3322
|
-0.968 10^3 cells/microliter
Standard Deviation 1.6410
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Neutrophils (abs)
|
0.137 10^3 cells/microliter
Standard Deviation 0.9677
|
0.092 10^3 cells/microliter
Standard Deviation 1.5919
|
-0.398 10^3 cells/microliter
Standard Deviation 0.3572
|
-0.020 10^3 cells/microliter
Standard Deviation 1.9093
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Neutrophils(abs)
|
0.413 10^3 cells/microliter
Standard Deviation 1.3356
|
-0.188 10^3 cells/microliter
Standard Deviation 0.7241
|
0.088 10^3 cells/microliter
Standard Deviation 0.4068
|
-0.972 10^3 cells/microliter
Standard Deviation 1.1744
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Neutrophils(abs)
|
—
|
-0.035 10^3 cells/microliter
Standard Deviation 1.3786
|
0.838 10^3 cells/microliter
Standard Deviation 1.8792
|
-0.815 10^3 cells/microliter
Standard Deviation 1.3199
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Eosinophils (abs)
|
0.212 10^3 cells/microliter
Standard Deviation 0.1298
|
0.242 10^3 cells/microliter
Standard Deviation 0.0823
|
0.208 10^3 cells/microliter
Standard Deviation 0.1338
|
0.162 10^3 cells/microliter
Standard Deviation 0.1005
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Eosinophils (abs)
|
0.012 10^3 cells/microliter
Standard Deviation 0.0638
|
0.020 10^3 cells/microliter
Standard Deviation 0.0994
|
0.012 10^3 cells/microliter
Standard Deviation 0.0676
|
0.027 10^3 cells/microliter
Standard Deviation 0.0871
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Eosinophils (abs)
|
-0.002 10^3 cells/microliter
Standard Deviation 0.0898
|
0.012 10^3 cells/microliter
Standard Deviation 0.1215
|
0.017 10^3 cells/microliter
Standard Deviation 0.0909
|
-0.007 10^3 cells/microliter
Standard Deviation 0.0628
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Eosinophils (abs)
|
-0.007 10^3 cells/microliter
Standard Deviation 0.0547
|
0.074 10^3 cells/microliter
Standard Deviation 0.0832
|
-0.008 10^3 cells/microliter
Standard Deviation 0.0643
|
0.043 10^3 cells/microliter
Standard Deviation 0.0842
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Eosinophils (abs)
|
-0.008 10^3 cells/microliter
Standard Deviation 0.0685
|
0.053 10^3 cells/microliter
Standard Deviation 0.1285
|
-0.045 10^3 cells/microliter
Standard Deviation 0.0547
|
0.058 10^3 cells/microliter
Standard Deviation 0.1003
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Eosinophils (abs)
|
0.028 10^3 cells/microliter
Standard Deviation 0.0567
|
-0.005 10^3 cells/microliter
Standard Deviation 0.0892
|
-0.078 10^3 cells/microliter
Standard Deviation 0.0652
|
0.032 10^3 cells/microliter
Standard Deviation 0.0750
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Monocytes (abs)
|
-0.005 10^3 cells/microliter
Standard Deviation 0.1566
|
-0.017 10^3 cells/microliter
Standard Deviation 0.1216
|
-0.128 10^3 cells/microliter
Standard Deviation 0.0781
|
-0.080 10^3 cells/microliter
Standard Deviation 0.0718
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Monocytes (abs)
|
-0.023 10^3 cells/microliter
Standard Deviation 0.1649
|
-0.025 10^3 cells/microliter
Standard Deviation 0.1154
|
-0.077 10^3 cells/microliter
Standard Deviation 0.0789
|
-0.080 10^3 cells/microliter
Standard Deviation 0.1259
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Eosinophils (abs)
|
-0.042 10^3 cells/microliter
Standard Deviation 0.0786
|
0.012 10^3 cells/microliter
Standard Deviation 0.0467
|
-0.082 10^3 cells/microliter
Standard Deviation 0.0891
|
0.030 10^3 cells/microliter
Standard Deviation 0.0903
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Eosinophils(abs)
|
-0.015 10^3 cells/microliter
Standard Deviation 0.0740
|
0.002 10^3 cells/microliter
Standard Deviation 0.0830
|
-0.057 10^3 cells/microliter
Standard Deviation 0.0831
|
0.076 10^3 cells/microliter
Standard Deviation 0.1328
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Eosinophils(abs)
|
—
|
-0.010 10^3 cells/microliter
Standard Deviation 0.1122
|
-0.010 10^3 cells/microliter
Standard Deviation 0.0447
|
0.075 10^3 cells/microliter
Standard Deviation 0.1318
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Basophils (abs)
|
0.032 10^3 cells/microliter
Standard Deviation 0.0133
|
0.048 10^3 cells/microliter
Standard Deviation 0.0371
|
0.032 10^3 cells/microliter
Standard Deviation 0.0214
|
0.030 10^3 cells/microliter
Standard Deviation 0.0200
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Basophils (abs)
|
0.014 10^3 cells/microliter
Standard Deviation 0.0358
|
-0.012 10^3 cells/microliter
Standard Deviation 0.0549
|
0.002 10^3 cells/microliter
Standard Deviation 0.0349
|
-0.003 10^3 cells/microliter
Standard Deviation 0.0258
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Basophils (abs)
|
0.003 10^3 cells/microliter
Standard Deviation 0.0137
|
-0.016 10^3 cells/microliter
Standard Deviation 0.0611
|
0.008 10^3 cells/microliter
Standard Deviation 0.0214
|
-0.005 10^3 cells/microliter
Standard Deviation 0.0176
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Basophils (abs)
|
0.007 10^3 cells/microliter
Standard Deviation 0.0175
|
-0.014 10^3 cells/microliter
Standard Deviation 0.0404
|
-0.008 10^3 cells/microliter
Standard Deviation 0.0204
|
0.000 10^3 cells/microliter
Standard Deviation 0.0216
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Basophils (abs)
|
0.003 10^3 cells/microliter
Standard Deviation 0.0103
|
-0.022 10^3 cells/microliter
Standard Deviation 0.0422
|
0.008 10^3 cells/microliter
Standard Deviation 0.0194
|
0.002 10^3 cells/microliter
Standard Deviation 0.0217
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Basophils (abs)
|
0.003 10^3 cells/microliter
Standard Deviation 0.0137
|
-0.027 10^3 cells/microliter
Standard Deviation 0.0344
|
-0.003 10^3 cells/microliter
Standard Deviation 0.0225
|
0.000 10^3 cells/microliter
Standard Deviation 0.0265
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Monocytes (abs)
|
—
|
0.012 10^3 cells/microliter
Standard Deviation 0.1620
|
-0.017 10^3 cells/microliter
Standard Deviation 0.1188
|
-0.065 10^3 cells/microliter
Standard Deviation 0.0915
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Basophils (abs)
|
0.005 10^3 cells/microliter
Standard Deviation 0.0266
|
-0.025 10^3 cells/microliter
Standard Deviation 0.0378
|
-0.007 10^3 cells/microliter
Standard Deviation 0.0225
|
0.022 10^3 cells/microliter
Standard Deviation 0.0363
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Basophils (abs)
|
-0.008 10^3 cells/microliter
Standard Deviation 0.0147
|
-0.027 10^3 cells/microliter
Standard Deviation 0.0294
|
0.007 10^3 cells/microliter
Standard Deviation 0.0378
|
0.012 10^3 cells/microliter
Standard Deviation 0.0179
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Basophils (abs)
|
—
|
-0.028 10^3 cells/microliter
Standard Deviation 0.0223
|
-0.012 10^3 cells/microliter
Standard Deviation 0.0256
|
0.010 10^3 cells/microliter
Standard Deviation 0.0082
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Lymphocytes (abs)
|
1.470 10^3 cells/microliter
Standard Deviation 0.3329
|
1.528 10^3 cells/microliter
Standard Deviation 0.3669
|
1.748 10^3 cells/microliter
Standard Deviation 0.4477
|
1.598 10^3 cells/microliter
Standard Deviation 0.3810
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Lymphocytes (abs)
|
-0.160 10^3 cells/microliter
Standard Deviation 0.2853
|
-0.088 10^3 cells/microliter
Standard Deviation 0.2491
|
-0.198 10^3 cells/microliter
Standard Deviation 0.1997
|
-0.197 10^3 cells/microliter
Standard Deviation 0.3760
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Lymphocytes (abs)
|
-0.042 10^3 cells/microliter
Standard Deviation 0.1594
|
-0.190 10^3 cells/microliter
Standard Deviation 0.2155
|
0.023 10^3 cells/microliter
Standard Deviation 0.2467
|
-0.273 10^3 cells/microliter
Standard Deviation 0.3223
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Lymphocytes (abs)
|
-0.063 10^3 cells/microliter
Standard Deviation 0.1973
|
-0.256 10^3 cells/microliter
Standard Deviation 0.4282
|
-0.090 10^3 cells/microliter
Standard Deviation 0.1452
|
-0.108 10^3 cells/microliter
Standard Deviation 0.0171
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Lymphocytes (abs)
|
0.023 10^3 cells/microliter
Standard Deviation 0.2299
|
-0.145 10^3 cells/microliter
Standard Deviation 0.3142
|
-0.303 10^3 cells/microliter
Standard Deviation 0.2717
|
-0.238 10^3 cells/microliter
Standard Deviation 0.3872
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Lymphocytes (abs)
|
0.012 10^3 cells/microliter
Standard Deviation 0.2175
|
-0.188 10^3 cells/microliter
Standard Deviation 0.2584
|
-0.293 10^3 cells/microliter
Standard Deviation 0.0907
|
-0.084 10^3 cells/microliter
Standard Deviation 0.4824
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Lymphocytes (abs)
|
-0.173 10^3 cells/microliter
Standard Deviation 0.2486
|
-0.192 10^3 cells/microliter
Standard Deviation 0.1985
|
-0.192 10^3 cells/microliter
Standard Deviation 0.2218
|
-0.152 10^3 cells/microliter
Standard Deviation 0.5413
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Lymphocytes(abs)
|
-0.025 10^3 cells/microliter
Standard Deviation 0.3961
|
-0.200 10^3 cells/microliter
Standard Deviation 0.1579
|
-0.048 10^3 cells/microliter
Standard Deviation 0.2303
|
0.118 10^3 cells/microliter
Standard Deviation 0.3841
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Lymphocytes(abs)
|
—
|
-0.128 10^3 cells/microliter
Standard Deviation 0.2971
|
-0.180 10^3 cells/microliter
Standard Deviation 0.3600
|
-0.180 10^3 cells/microliter
Standard Deviation 0.1911
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Monocytes (abs)
|
0.522 10^3 cells/microliter
Standard Deviation 0.1622
|
0.455 10^3 cells/microliter
Standard Deviation 0.1440
|
0.525 10^3 cells/microliter
Standard Deviation 0.1169
|
0.542 10^3 cells/microliter
Standard Deviation 0.1569
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Monocytes (abs)
|
-0.034 10^3 cells/microliter
Standard Deviation 0.1826
|
-0.033 10^3 cells/microliter
Standard Deviation 0.0898
|
-0.084 10^3 cells/microliter
Standard Deviation 0.0899
|
-0.127 10^3 cells/microliter
Standard Deviation 0.1488
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Monocytes (abs)
|
-0.043 10^3 cells/microliter
Standard Deviation 0.1229
|
-0.020 10^3 cells/microliter
Standard Deviation 0.0265
|
-0.095 10^3 cells/microliter
Standard Deviation 0.0517
|
-0.133 10^3 cells/microliter
Standard Deviation 0.1402
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Monocytes (abs)
|
0.000 10^3 cells/microliter
Standard Deviation 0.0701
|
-0.017 10^3 cells/microliter
Standard Deviation 0.1061
|
-0.203 10^3 cells/microliter
Standard Deviation 0.1183
|
-0.090 10^3 cells/microliter
Standard Deviation 0.0620
|
|
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Monocytes (abs)
|
-0.020 10^3 cells/microliter
Standard Deviation 0.1753
|
-0.013 10^3 cells/microliter
Standard Deviation 0.1058
|
-0.177 10^3 cells/microliter
Standard Deviation 0.2366
|
-0.068 10^3 cells/microliter
Standard Deviation 0.1283
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Following hematology parameters were analyzed for laboratory examination: Prothrombin Time (PT), Partial Thromboplastin Time.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: PT
|
11.82 Second
Standard Deviation 0.556
|
11.53 Second
Standard Deviation 0.505
|
11.10 Second
Standard Deviation 1.056
|
11.90 Second
Standard Deviation 1.220
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: PT
|
-0.55 Second
Standard Deviation 0.362
|
-0.02 Second
Standard Deviation 0.248
|
0.18 Second
Standard Deviation 0.896
|
-0.58 Second
Standard Deviation 1.143
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: PT
|
0.10 Second
Standard Deviation 0.758
|
-0.28 Second
Standard Deviation 0.920
|
0.12 Second
Standard Deviation 0.766
|
-0.27 Second
Standard Deviation 2.025
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: PT
|
-0.25 Second
Standard Deviation 0.327
|
-0.12 Second
Standard Deviation 0.676
|
0.37 Second
Standard Deviation 1.221
|
-0.95 Second
Standard Deviation 1.353
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: PT
|
0.20 Second
Standard Deviation 1.259
|
-0.43 Second
Standard Deviation 0.308
|
0.60 Second
Standard Deviation 1.356
|
-1.00 Second
Standard Deviation 1.383
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: PT
|
0.47 Second
Standard Deviation 0.700
|
0.17 Second
Standard Deviation 0.802
|
0.24 Second
Standard Deviation 0.820
|
-0.26 Second
Standard Deviation 2.019
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: PT
|
-0.32 Second
Standard Deviation 1.326
|
-0.37 Second
Standard Deviation 0.871
|
0.15 Second
Standard Deviation 0.609
|
-0.80 Second
Standard Deviation 1.037
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: PT
|
-0.67 Second
Standard Deviation 0.931
|
-0.42 Second
Standard Deviation 0.407
|
-0.28 Second
Standard Deviation 0.783
|
-0.77 Second
Standard Deviation 1.510
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: PT
|
—
|
-0.05 Second
Standard Deviation 0.750
|
-0.73 Second
Standard Deviation 0.528
|
-0.42 Second
Standard Deviation 2.050
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: PTT
|
31.12 Second
Standard Deviation 3.842
|
32.57 Second
Standard Deviation 4.457
|
31.63 Second
Standard Deviation 6.808
|
31.23 Second
Standard Deviation 5.460
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: PTT
|
-1.77 Second
Standard Deviation 4.431
|
-0.33 Second
Standard Deviation 1.490
|
-3.86 Second
Standard Deviation 5.106
|
0.17 Second
Standard Deviation 2.521
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: PTT
|
-4.64 Second
Standard Deviation 7.314
|
0.45 Second
Standard Deviation 2.338
|
-1.00 Second
Standard Deviation 7.216
|
-0.52 Second
Standard Deviation 3.801
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: PTT
|
-3.08 Second
Standard Deviation 4.275
|
0.44 Second
Standard Deviation 2.235
|
1.73 Second
Standard Deviation 12.794
|
0.00 Second
Standard Deviation 2.302
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: PTT
|
-0.18 Second
Standard Deviation 6.184
|
-2.42 Second
Standard Deviation 2.870
|
1.06 Second
Standard Deviation 5.949
|
-0.02 Second
Standard Deviation 1.424
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: PTT
|
0.18 Second
Standard Deviation 5.651
|
-2.02 Second
Standard Deviation 1.105
|
0.22 Second
Standard Deviation 6.524
|
-2.02 Second
Standard Deviation 2.751
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: PTT
|
-1.83 Second
Standard Deviation 4.898
|
-0.48 Second
Standard Deviation 3.284
|
2.78 Second
Standard Deviation 8.713
|
-0.52 Second
Standard Deviation 2.840
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: PTT
|
-2.47 Second
Standard Deviation 3.686
|
0.90 Second
Standard Deviation 4.901
|
1.68 Second
Standard Deviation 6.563
|
-0.28 Second
Standard Deviation 2.869
|
|
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: PTT
|
—
|
1.92 Second
Standard Deviation 3.381
|
4.83 Second
Standard Deviation 5.654
|
3.95 Second
Standard Deviation 8.973
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Urine specific gravity is a measure of the ratio of the density of urine to the density of water.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: USG
|
-0.0002 ratio
Standard Deviation 0.00462
|
-0.0020 ratio
Standard Deviation 0.00447
|
0.0015 ratio
Standard Deviation 0.00650
|
-0.0022 ratio
Standard Deviation 0.00492
|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: USG
|
0.0008 ratio
Standard Deviation 0.00884
|
-0.0012 ratio
Standard Deviation 0.00559
|
0.0045 ratio
Standard Deviation 0.00568
|
-0.0024 ratio
Standard Deviation 0.00493
|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: USG
|
-0.0013 ratio
Standard Deviation 0.00266
|
-0.0003 ratio
Standard Deviation 0.00497
|
0.0038 ratio
Standard Deviation 0.00366
|
-0.0022 ratio
Standard Deviation 0.00527
|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: USG
|
—
|
-0.0028 ratio
Standard Deviation 0.00768
|
0.0058 ratio
Standard Deviation 0.00591
|
-0.0010 ratio
Standard Deviation 0.00566
|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: USG
|
1.0197 ratio
Standard Deviation 0.00565
|
1.0150 ratio
Standard Deviation 0.00529
|
1.0138 ratio
Standard Deviation 0.00343
|
1.0242 ratio
Standard Deviation 0.00615
|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: USG
|
-0.0018 ratio
Standard Deviation 0.00950
|
0.0012 ratio
Standard Deviation 0.00462
|
0.0020 ratio
Standard Deviation 0.00636
|
-0.0043 ratio
Standard Deviation 0.00383
|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: USG
|
-0.0018 ratio
Standard Deviation 0.00741
|
-0.0003 ratio
Standard Deviation 0.00787
|
0.0022 ratio
Standard Deviation 0.00293
|
-0.0025 ratio
Standard Deviation 0.00259
|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: USG
|
-0.0010 ratio
Standard Deviation 0.00654
|
-0.0008 ratio
Standard Deviation 0.00376
|
-0.0002 ratio
Standard Deviation 0.00293
|
-0.0020 ratio
Standard Deviation 0.00474
|
|
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: USG
|
-0.0010 ratio
Standard Deviation 0.00940
|
-0.0005 ratio
Standard Deviation 0.00625
|
0.0047 ratio
Standard Deviation 0.00680
|
0.0002 ratio
Standard Deviation 0.00277
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Urine pH is a method for evaluating urine acidity measured on a 10-point scale ranging from 0 (most acidic) to 9 (most alkaline). A lower pH means more acidity.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: Urine pH
|
6.33 units on a scale
Standard Deviation 0.408
|
5.92 units on a scale
Standard Deviation 0.376
|
6.00 units on a scale
Standard Deviation 0.000
|
6.00 units on a scale
Standard Deviation 0.316
|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: Urine pH
|
-0.17 units on a scale
Standard Deviation 0.258
|
0.42 units on a scale
Standard Deviation 0.376
|
0.30 units on a scale
Standard Deviation 0.447
|
-0.08 units on a scale
Standard Deviation 0.492
|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: Urine pH
|
0.00 units on a scale
Standard Deviation 0.447
|
0.17 units on a scale
Standard Deviation 0.408
|
0.08 units on a scale
Standard Deviation 0.204
|
0.08 units on a scale
Standard Deviation 0.585
|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: Urine pH
|
-0.08 units on a scale
Standard Deviation 0.376
|
0.00 units on a scale
Standard Deviation 0.447
|
0.25 units on a scale
Standard Deviation 0.524
|
0.20 units on a scale
Standard Deviation 0.274
|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: Urine pH
|
0.08 units on a scale
Standard Deviation 0.585
|
0.00 units on a scale
Standard Deviation 0.316
|
0.17 units on a scale
Standard Deviation 0.408
|
-0.20 units on a scale
Standard Deviation 0.570
|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: Urine pH
|
-0.25 units on a scale
Standard Deviation 0.274
|
0.50 units on a scale
Standard Deviation 0.548
|
0.25 units on a scale
Standard Deviation 0.524
|
0.00 units on a scale
Standard Deviation 0.500
|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: Urine pH
|
-0.08 units on a scale
Standard Deviation 0.492
|
0.30 units on a scale
Standard Deviation 0.671
|
0.17 units on a scale
Standard Deviation 0.516
|
0.00 units on a scale
Standard Deviation 0.354
|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: Urine pH
|
-0.17 units on a scale
Standard Deviation 0.408
|
0.25 units on a scale
Standard Deviation 0.689
|
0.75 units on a scale
Standard Deviation 0.935
|
-0.17 units on a scale
Standard Deviation 0.258
|
|
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: Urine pH
|
—
|
0.33 units on a scale
Standard Deviation 0.408
|
0.25 units on a scale
Standard Deviation 0.418
|
-0.13 units on a scale
Standard Deviation 0.479
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Baseline: IL-6
|
0.00 Picogram per milliliter (pg/ml)
Standard Deviation 0.000
|
1.22 Picogram per milliliter (pg/ml)
Standard Deviation 1.354
|
0.62 Picogram per milliliter (pg/ml)
Standard Deviation 1.511
|
0.52 Picogram per milliliter (pg/ml)
Standard Deviation 1.163
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Baseline: beta IL-1
|
0.00 Picogram per milliliter (pg/ml)
Standard Deviation 0.000
|
—
|
—
|
0.00 Picogram per milliliter (pg/ml)
Standard Deviation 0.000
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 28: beta IL-1
|
0.32 Picogram per milliliter (pg/ml)
Standard Deviation 0.776
|
—
|
—
|
0.00 Picogram per milliliter (pg/ml)
Standard Deviation 0.000
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 56: beta IL-1
|
0.00 Picogram per milliliter (pg/ml)
Standard Deviation 0.000
|
—
|
—
|
0.00 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 84: beta IL-1
|
0.40 Picogram per milliliter (pg/ml)
Standard Deviation 0.980
|
—
|
—
|
0.00 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 112: beta IL-1
|
0.00 Picogram per milliliter (pg/ml)
Standard Deviation 0.000
|
—
|
—
|
0.00 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 140: beta IL-1
|
0.23 Picogram per milliliter (pg/ml)
Standard Deviation 0.572
|
—
|
—
|
0.00 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 28: IL-6
|
0.90 Picogram per milliliter (pg/ml)
Standard Deviation 1.445
|
-1.22 Picogram per milliliter (pg/ml)
Standard Deviation 1.354
|
1.23 Picogram per milliliter (pg/ml)
Standard Deviation 4.190
|
0.34 Picogram per milliliter (pg/ml)
Standard Deviation 0.760
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 56: IL-6
|
0.67 Picogram per milliliter (pg/ml)
Standard Deviation 1.633
|
-1.22 Picogram per milliliter (pg/ml)
Standard Deviation 1.354
|
0.10 Picogram per milliliter (pg/ml)
Standard Deviation 3.186
|
0.20 Picogram per milliliter (pg/ml)
Standard Deviation 0.400
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 84: IL-6
|
0.00 Picogram per milliliter (pg/ml)
Standard Deviation 0.000
|
1.50 Picogram per milliliter (pg/ml)
Standard Deviation 2.386
|
-0.05 Picogram per milliliter (pg/ml)
Standard Deviation 2.247
|
0.50 Picogram per milliliter (pg/ml)
Standard Deviation 1.000
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 112: IL-6
|
1.84 Picogram per milliliter (pg/ml)
Standard Deviation 2.855
|
-0.05 Picogram per milliliter (pg/ml)
Standard Deviation 2.002
|
-0.62 Picogram per milliliter (pg/ml)
Standard Deviation 1.511
|
0.55 Picogram per milliliter (pg/ml)
Standard Deviation 1.168
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 140: IL-6
|
0.00 Picogram per milliliter (pg/ml)
Standard Deviation 0.000
|
0.90 Picogram per milliliter (pg/ml)
Standard Deviation 3.366
|
3.38 Picogram per milliliter (pg/ml)
Standard Deviation 5.754
|
1.63 Picogram per milliliter (pg/ml)
Standard Deviation 1.950
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Baseline: alpha TNF
|
2.943 Picogram per milliliter (pg/ml)
Standard Deviation 1.7942
|
—
|
—
|
3.185 Picogram per milliliter (pg/ml)
Standard Deviation 1.2657
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 28: alpha TNF
|
1.175 Picogram per milliliter (pg/ml)
Standard Deviation 2.0170
|
—
|
—
|
-1.425 Picogram per milliliter (pg/ml)
Standard Deviation 1.2233
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 56: alpha TNF
|
0.590 Picogram per milliliter (pg/ml)
Standard Deviation 2.2536
|
—
|
—
|
0.790 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 84: alpha TNF
|
1.423 Picogram per milliliter (pg/ml)
Standard Deviation 1.2367
|
—
|
—
|
0.520 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 112: alpha TNF
|
1.762 Picogram per milliliter (pg/ml)
Standard Deviation 1.5999
|
—
|
—
|
1.140 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 140: alpha TNF
|
1.512 Picogram per milliliter (pg/ml)
Standard Deviation 1.4736
|
—
|
—
|
1.220 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Baseline: INF (Gamma)
|
0.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
—
|
—
|
0.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 28: INF (Gamma)
|
0.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
—
|
—
|
0.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 56: INF (Gamma)
|
0.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
—
|
—
|
0.0 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 84: INF (Gamma)
|
0.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
—
|
—
|
0.0 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 112: INF (Gamma)
|
0.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
—
|
—
|
0.0 Picogram per milliliter (pg/ml)
|
|
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Change at Day 140: INF (Gamma)
|
0.0 Picogram per milliliter (pg/ml)
Standard Deviation 0.00
|
—
|
—
|
0.0 Picogram per milliliter (pg/ml)
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Baseline: C3A
|
970.3 Nanogram per milliliter (ng/mL)
Standard Deviation 214.77
|
928.0 Nanogram per milliliter (ng/mL)
Standard Deviation 228.37
|
1465.8 Nanogram per milliliter (ng/mL)
Standard Deviation 352.95
|
1813.0 Nanogram per milliliter (ng/mL)
Standard Deviation 1060.66
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 28: C3A
|
560.2 Nanogram per milliliter (ng/mL)
Standard Deviation 1109.51
|
447.5 Nanogram per milliliter (ng/mL)
Standard Deviation 457.21
|
161.3 Nanogram per milliliter (ng/mL)
Standard Deviation 523.83
|
-305.3 Nanogram per milliliter (ng/mL)
Standard Deviation 899.05
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 56: C3A )
|
404.7 Nanogram per milliliter (ng/mL)
Standard Deviation 280.70
|
221.0 Nanogram per milliliter (ng/mL)
Standard Deviation 202.67
|
-74.5 Nanogram per milliliter (ng/mL)
Standard Deviation 723.41
|
-220.6 Nanogram per milliliter (ng/mL)
Standard Deviation 231.43
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 84: C3A
|
380.3 Nanogram per milliliter (ng/mL)
Standard Deviation 341.07
|
290.2 Nanogram per milliliter (ng/mL)
Standard Deviation 414.07
|
-610.3 Nanogram per milliliter (ng/mL)
Standard Deviation 425.31
|
117.0 Nanogram per milliliter (ng/mL)
Standard Deviation 826.44
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 112: C3A
|
445.2 Nanogram per milliliter (ng/mL)
Standard Deviation 465.87
|
246.0 Nanogram per milliliter (ng/mL)
Standard Deviation 337.86
|
-129.5 Nanogram per milliliter (ng/mL)
Standard Deviation 454.93
|
746.2 Nanogram per milliliter (ng/mL)
Standard Deviation 1686.03
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 140: C3A
|
297.8 Nanogram per milliliter (ng/mL)
Standard Deviation 508.62
|
928.6 Nanogram per milliliter (ng/mL)
Standard Deviation 398.79
|
-68.3 Nanogram per milliliter (ng/mL)
Standard Deviation 543.15
|
-32.2 Nanogram per milliliter (ng/mL)
Standard Deviation 846.33
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Baseline: C5B-9
|
289.5 Nanogram per milliliter (ng/mL)
Standard Deviation 56.64
|
199.8 Nanogram per milliliter (ng/mL)
Standard Deviation 16.87
|
244.3 Nanogram per milliliter (ng/mL)
Standard Deviation 132.87
|
299.7 Nanogram per milliliter (ng/mL)
Standard Deviation 154.14
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 28: C5B-9
|
-33.5 Nanogram per milliliter (ng/mL)
Standard Deviation 83.69
|
-26.2 Nanogram per milliliter (ng/mL)
Standard Deviation 44.51
|
-63.0 Nanogram per milliliter (ng/mL)
Standard Deviation 131.56
|
-85.5 Nanogram per milliliter (ng/mL)
Standard Deviation 87.54
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 56: C5B-9
|
-78.0 Nanogram per milliliter (ng/mL)
Standard Deviation 47.76
|
11.3 Nanogram per milliliter (ng/mL)
Standard Deviation 59.09
|
0.0 Nanogram per milliliter (ng/mL)
Standard Deviation 50.73
|
-8.0 Nanogram per milliliter (ng/mL)
Standard Deviation 109.90
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 84: C5B-9
|
-9.8 Nanogram per milliliter (ng/mL)
Standard Deviation 152.15
|
16.6 Nanogram per milliliter (ng/mL)
Standard Deviation 105.20
|
34.5 Nanogram per milliliter (ng/mL)
Standard Deviation 102.80
|
4.8 Nanogram per milliliter (ng/mL)
Standard Deviation 86.14
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 112: C5B-9
|
-35.8 Nanogram per milliliter (ng/mL)
Standard Deviation 63.01
|
-15.3 Nanogram per milliliter (ng/mL)
Standard Deviation 36.68
|
51.8 Nanogram per milliliter (ng/mL)
Standard Deviation 106.84
|
42.6 Nanogram per milliliter (ng/mL)
Standard Deviation 99.64
|
|
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Change at Day 140: C5B-9
|
-36.8 Nanogram per milliliter (ng/mL)
Standard Deviation 69.42
|
-10.2 Nanogram per milliliter (ng/mL)
Standard Deviation 123.29
|
-13.3 Nanogram per milliliter (ng/mL)
Standard Deviation 98.95
|
-30.2 Nanogram per milliliter (ng/mL)
Standard Deviation 74.25
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140
Baseline: C4D
|
2.692 Microgram per milliliter (mcg/mL)
Standard Deviation 1.5264
|
—
|
—
|
3.720 Microgram per milliliter (mcg/mL)
Standard Deviation 2.2910
|
|
Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140
Change at Day 28: C4D
|
1.078 Microgram per milliliter (mcg/mL)
Standard Deviation 4.3643
|
—
|
—
|
-1.720 Microgram per milliliter (mcg/mL)
Standard Deviation 1.0748
|
|
Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140
Change at Day 56: C4D
|
-1.503 Microgram per milliliter (mcg/mL)
Standard Deviation 1.4911
|
—
|
—
|
-1.320 Microgram per milliliter (mcg/mL)
|
|
Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140
Change at Day 84: C4D
|
-0.907 Microgram per milliliter (mcg/mL)
Standard Deviation 1.6772
|
—
|
—
|
1.180 Microgram per milliliter (mcg/mL)
|
|
Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140
Change at Day 112: C4D
|
-0.466 Microgram per milliliter (mcg/mL)
Standard Deviation 1.6322
|
—
|
—
|
1.060 Microgram per milliliter (mcg/mL)
|
|
Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140
Change at Day 140: C4D
|
-0.338 Microgram per milliliter (mcg/mL)
Standard Deviation 1.6790
|
—
|
—
|
0.140 Microgram per milliliter (mcg/mL)
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: PT-INR
|
-0.058 Ratio
Standard Deviation 0.0776
|
0.047 Ratio
Standard Deviation 0.0344
|
0.060 Ratio
Standard Deviation 0.0651
|
-0.018 Ratio
Standard Deviation 0.1148
|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: PT-INR
|
0.995 Ratio
Standard Deviation 0.0455
|
0.972 Ratio
Standard Deviation 0.0436
|
0.933 Ratio
Standard Deviation 0.0871
|
1.017 Ratio
Standard Deviation 0.1167
|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 28: PT-INR
|
-0.047 Ratio
Standard Deviation 0.0288
|
-0.003 Ratio
Standard Deviation 0.0234
|
0.064 Ratio
Standard Deviation 0.1199
|
-0.050 Ratio
Standard Deviation 0.0925
|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 56: PT-INR
|
0.006 Ratio
Standard Deviation 0.0586
|
-0.027 Ratio
Standard Deviation 0.0755
|
0.096 Ratio
Standard Deviation 0.0623
|
0.000 Ratio
Standard Deviation 0.1802
|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 84: PT-INR
|
-0.022 Ratio
Standard Deviation 0.0256
|
0.004 Ratio
Standard Deviation 0.0522
|
0.117 Ratio
Standard Deviation 0.1076
|
-0.060 Ratio
Standard Deviation 0.1374
|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 112: PT-INR
|
0.014 Ratio
Standard Deviation 0.1001
|
-0.008 Ratio
Standard Deviation 0.0488
|
0.140 Ratio
Standard Deviation 0.1231
|
-0.062 Ratio
Standard Deviation 0.1284
|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 140: PT-INR
|
0.037 Ratio
Standard Deviation 0.0535
|
0.042 Ratio
Standard Deviation 0.0697
|
0.106 Ratio
Standard Deviation 0.0669
|
-0.006 Ratio
Standard Deviation 0.1757
|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: PT-INR
|
-0.027 Ratio
Standard Deviation 0.1078
|
-0.005 Ratio
Standard Deviation 0.0912
|
0.098 Ratio
Standard Deviation 0.0519
|
-0.050 Ratio
Standard Deviation 0.1077
|
|
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: PT-INR
|
—
|
0.085 Ratio
Standard Deviation 0.0599
|
0.055 Ratio
Standard Deviation 0.0481
|
0.050 Ratio
Standard Deviation 0.1927
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ETPopulation: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.
QT interval corrected using the Fridericia formula (QTcF) \>=500 msec; Maximum Change from Baseline in QTcF at Borderline \>=30 msec to \<60 msec and Prolonged \>=60 msec.
Outcome measures
| Measure |
RN6G 5 mg/kg
n=6 Participants
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 Participants
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 Participants
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 Participants
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Baseline: QTcF
|
414.22 Millisecond (msec)
Standard Deviation 13.474
|
427.89 Millisecond (msec)
Standard Deviation 21.462
|
420.56 Millisecond (msec)
Standard Deviation 20.579
|
412.06 Millisecond (msec)
Standard Deviation 20.201
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 1: QTcF
|
0.56 Millisecond (msec)
Standard Deviation 8.035
|
-1.50 Millisecond (msec)
Standard Deviation 4.732
|
3.06 Millisecond (msec)
Standard Deviation 8.762
|
3.86 Millisecond (msec)
Standard Deviation 13.329
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post-dose Day 1: QTcF
|
1.50 Millisecond (msec)
Standard Deviation 14.898
|
-8.78 Millisecond (msec)
Standard Deviation 13.480
|
1.50 Millisecond (msec)
Standard Deviation 13.328
|
9.50 Millisecond (msec)
Standard Deviation 28.659
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 28: QTcF
|
-4.72 Millisecond (msec)
Standard Deviation 15.874
|
-12.06 Millisecond (msec)
Standard Deviation 14.565
|
1.78 Millisecond (msec)
Standard Deviation 15.022
|
-2.06 Millisecond (msec)
Standard Deviation 8.410
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 56: QTcF
|
-2.22 Millisecond (msec)
Standard Deviation 13.404
|
-6.06 Millisecond (msec)
Standard Deviation 9.799
|
7.11 Millisecond (msec)
Standard Deviation 19.452
|
6.44 Millisecond (msec)
Standard Deviation 15.930
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 84: QTcF
|
-1.39 Millisecond (msec)
Standard Deviation 10.438
|
-9.72 Millisecond (msec)
Standard Deviation 14.220
|
6.11 Millisecond (msec)
Standard Deviation 20.435
|
19.00 Millisecond (msec)
Standard Deviation 24.226
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 112: QTcF
|
-5.22 Millisecond (msec)
Standard Deviation 8.005
|
-5.89 Millisecond (msec)
Standard Deviation 10.681
|
0.78 Millisecond (msec)
Standard Deviation 8.275
|
25.80 Millisecond (msec)
Standard Deviation 39.012
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at pre-dose Day 140: QTcF
|
-2.67 Millisecond (msec)
Standard Deviation 7.598
|
-0.11 Millisecond (msec)
Standard Deviation 8.614
|
8.61 Millisecond (msec)
Standard Deviation 7.672
|
8.87 Millisecond (msec)
Standard Deviation 23.092
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 1 H post-dose Day 140: QTcF
|
-2.28 Millisecond (msec)
Standard Deviation 9.488
|
-15.83 Millisecond (msec)
Standard Deviation 36.907
|
10.61 Millisecond (msec)
Standard Deviation 11.174
|
14.13 Millisecond (msec)
Standard Deviation 15.604
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at 4 H post dose Day 140: QTcF
|
-3.17 Millisecond (msec)
Standard Deviation 7.001
|
-3.28 Millisecond (msec)
Standard Deviation 8.510
|
12.72 Millisecond (msec)
Standard Deviation 8.172
|
11.60 Millisecond (msec)
Standard Deviation 19.991
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 168: QTcF
|
-8.56 Millisecond (msec)
Standard Deviation 16.363
|
-1.22 Millisecond (msec)
Standard Deviation 12.523
|
7.94 Millisecond (msec)
Standard Deviation 18.671
|
8.40 Millisecond (msec)
Standard Deviation 21.483
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 224/ET: QTcF
|
-4.39 Millisecond (msec)
Standard Deviation 6.533
|
-11.22 Millisecond (msec)
Standard Deviation 11.485
|
1.94 Millisecond (msec)
Standard Deviation 16.996
|
10.94 Millisecond (msec)
Standard Deviation 17.055
|
|
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Change at Day 304/ET: QTcF
|
—
|
-6.72 Millisecond (msec)
Standard Deviation 14.685
|
-7.39 Millisecond (msec)
Standard Deviation 21.754
|
11.50 Millisecond (msec)
Standard Deviation 18.165
|
Adverse Events
RN6G 5 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
RN6G 10 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
RN6G 15 mg/kg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RN6G 5 mg/kg
n=6 participants at risk
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 participants at risk
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 participants at risk
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 participants at risk
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
RN6G 5 mg/kg
n=6 participants at risk
RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 10 mg/kg
n=6 participants at risk
RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
RN6G 15 mg/kg
n=6 participants at risk
RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
|
Placebo
n=6 participants at risk
Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Venous injury
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear disorder
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Age-related macular degeneration
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Blepharitis
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Night blindness
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Optic nerve sheath haemorrhage
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Retinal depigmentation
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Retinal exudates
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Retinal pigmentation
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vitreous floaters
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Immune system disorder
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacterial infection
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal infection
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
4/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Bacterial test positive
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Bilirubin urine
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose abnormal
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood urea increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Complement factor C3 increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Complement factor increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haematocrit increased
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Occult blood positive
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Optic nerve cup/disc ratio increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet morphology abnormal
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Protein urine present
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Prothrombin time prolonged
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cell burr cells present
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Urinary sediment present
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Urine leukocyte esterase positive
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Visual field tests abnormal
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cells urine positive
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Cholesterosis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Balance disorder
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Essential hypertension
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER