Trial Outcomes & Findings for Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men. (NCT NCT01293487)
NCT ID: NCT01293487
Last Updated: 2024-09-24
Results Overview
Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose level was also be considered intolerable if, in the judgment of the Investigator and Sponsor, the type, frequency, or severity of AEs becomes unacceptable.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
Day 1 to Day 85
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
PF-04840082 0.3 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
8
|
8
|
20
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
8
|
8
|
8
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
PF-04840082 0.3 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
Baseline characteristics by cohort
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
61.3 years
STANDARD_DEVIATION 5.5 • n=21 Participants
|
63.6 years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
61.3 years
STANDARD_DEVIATION 5.2 • n=8 Participants
|
62.8 years
STANDARD_DEVIATION 5.1 • n=24 Participants
|
62.5 years
STANDARD_DEVIATION 5.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
50 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 85Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose level was also be considered intolerable if, in the judgment of the Investigator and Sponsor, the type, frequency, or severity of AEs becomes unacceptable.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting or Intolerable Treatment Related Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 85Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: 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 life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With All-Causality AEs by Grade
Grade 1
|
100.0 percentage of participants
|
50.0 percentage of participants
|
100.0 percentage of participants
|
66.7 percentage of participants
|
62.5 percentage of participants
|
37.5 percentage of participants
|
62.5 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With All-Causality AEs by Grade
Grade 3
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With All-Causality AEs by Grade
Grade 2
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
12.5 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With All-Causality AEs by Grade
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With All-Causality AEs by Grade
Grade 5
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With All-Causality AEs by Grade
Missing/Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 85Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity was graded as Grade 1: 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 life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Relatedness to drug was assessed by investigator.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-Related AEs by Grade
Grade 2
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-Related AEs by Grade
Grade 3
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-Related AEs by Grade
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-Related AEs by Grade
Missing/Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-Related AEs by Grade
Grade 1
|
50.0 percentage of participants
|
16.7 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
37.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Treatment-Related AEs by Grade
Grade 5
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to 85Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Criteria for abnormality: hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function: blood urea nitrogen, creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium\>1.05\*ULN, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN), urine casts, granular casts, hyaline casts\>1 LPF; hormones: T4, T3, TSH\<0.8\*LLN.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Laboratory Abnormality
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Median change from baseline in platelets, WBC count, lymphocytes (absolute \[Abs\]), total neutrophils (Abs), basophils (Abs), eosinophils (Abs), and monocytes (Abs)
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
White Blood Cell Count
|
-0.8 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.5 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.9 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.8 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.4 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Lymphocytes (Abs)
|
-0.10 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.06 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.06 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.06 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.07 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.05 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.09 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Eosinophils (Abs)
|
0.03 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.04 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Platelets
|
8 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-9 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
7 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
4 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-3 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-31 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-5 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-6 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Total Neutrophils (Abs)
|
-0.78 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.04 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.34 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.51 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.12 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.61 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.11 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.35 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Basophils (Abs)
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Platelets and White Blood Cell [WBC] Count (With Differentials) at Last Observation
Monocytes (Abs)
|
-0.10 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.04 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.04 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.03 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.03 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.00 10^3 cells/millimeter cube (mm^3)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Red Blood Cell (RBC) Count at Last Observation
|
-0.05 10^6 cells/mm^3
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.07 10^6 cells/mm^3
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.14 10^6 cells/mm^3
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.10 10^6 cells/mm^3
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.05 10^6 cells/mm^3
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.30 10^6 cells/mm^3
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.06 10^6 cells/mm^3
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.07 10^6 cells/mm^3
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Hematocrit at Last Observation
|
0.6 percentage of red blood cells
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1.4 percentage of red blood cells
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.8 percentage of red blood cells
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.4 percentage of red blood cells
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1.0 percentage of red blood cells
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-2.4 percentage of red blood cells
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.5 percentage of red blood cells
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.8 percentage of red blood cells
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation
Albumin
|
-0.3 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.0 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.2 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.3 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation
Hemoglobin (HGB)
|
-0.3 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.6 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.6 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.8 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.4 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Hemoglobin, Total Protein, and Albumin at Last Observation
Total Protein
|
-0.5 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.3 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.1 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.2 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.3 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.0 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 grams/deciliter (g/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Includes median changes from baseline in total bilirubin, direct bilirubin, indirect bilirubin, blood urea nitrogen (BUN), creatinine, uric acid, calcium, magnesium, and glucose
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Uric Acid
|
-1.0 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Glucose
|
-11 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
2 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
3 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-11 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Total Bilirubin
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Direct Bilirubin
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Indirect Bilirubin
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Blood Urea Nitrogen (BUN)
|
-4.7 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
5.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-3.5 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
3.8 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-2.1 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1.2 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1.3 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.4 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Creatinine
|
-0.1 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.1 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.1 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Calcium
|
-0.2 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Select Clinical Chemistry Parameters at Last Observation
Magnesium
|
-0.1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.0 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milligrams/dL (mg/dL)
Analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
Sodium
|
-1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
Bicarbonate (venous)
|
0.2 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.3 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.6 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1.5 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.3 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.3 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
Chloride
|
-1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
2 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Sodium, Potassium, Chloride, and Bicarbonate at Last Observation
Potassium
|
0.1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.2 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.3 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.3 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.2 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.1 milliequivalents (mEq)/liter (L)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Includes median changes in aspartate aminotransferase (AST), alanine aminotransferase (AST), gamma glutamyltransferase (GGT), and alkaline phosphatase
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Liver Function Tests at Last Observation
Alanine Aminotransferase (ALT)
|
0 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-3 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
2 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-8 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Liver Function Tests at Last Observation
Aminotransferase (AST)
|
-1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-2 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
2 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Liver Function Tests at Last Observation
Gamma GT
|
-8 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-6 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-2 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
4 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-3 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
3 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Liver Function Tests at Last Observation
Alkaline Phosphatase
|
1 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-5 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
4 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
10 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
7 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-2 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-5 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-3 international units (IU)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, Last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Thyroid-Stimulating Hormone (TSH) at Last Observation
|
0 micro IU (mIU)/mL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 micro IU (mIU)/mL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 micro IU (mIU)/mL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0 micro IU (mIU)/mL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 micro IU (mIU)/mL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 micro IU (mIU)/mL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 micro IU (mIU)/mL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 micro IU (mIU)/mL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, Last Observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation
Amylase
|
5 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
4 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
7 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-12 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation
Lipase
|
-1 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
5 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-8 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
14 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-7 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-8 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-3 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
4 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Serum Creatine Kinase (CK), Amylase, and Lipase at Last Observation
Creatine Kinase (CK)
|
-17 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
21 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-43 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
13 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
1 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-11 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
4 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-16 units (U)/L
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication. Here "0" in the "overall number of participants analyzed" signifies that data not collected because none of the participants were evaluable for the specified arm.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation
T3 (free)
|
—
|
—
|
-0.0 nanograms (ng)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
—
|
-0.0 nanograms (ng)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
—
|
—
|
-0.0 nanograms (ng)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
|
Median Change From Baseline in Free Triiodothyronine (T3) and Free Thyroxine (T4) at Last Observation
T4 (free)
|
—
|
—
|
-0.0 nanograms (ng)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
—
|
0.0 nanograms (ng)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
—
|
—
|
0.0 nanograms (ng)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication. Here "0" in the "overall number of participants analyzed" signifies that data not collected because none of the participants were evaluable for the specified arm.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in T4 at Last Observation
|
0.3 micrograms (mcg)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.9 micrograms (mcg)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-1.6 micrograms (mcg)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 micrograms (mcg)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
—
|
-0.3 micrograms (mcg)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.2 micrograms (mcg)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.1 micrograms (mcg)/dL
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication. Here "0" in the "overall number of participants analyzed" signifies that data not collected because none of the participants were evaluable for the specified arm.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Urine WBC at Last Observation
|
—
|
-1.0 /high-powered field (HPF)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
—
|
0.0 /high-powered field (HPF)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
—
|
—
|
—
|
-1.0 /high-powered field (HPF)
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Baseline, last observation (up to Day 85)Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Median Change From Baseline in Urine pH at Last Observation
|
0.3 pH
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.7 pH
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.3 pH
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 pH
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.6 pH
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
-0.3 pH
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.0 pH
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
0.3 pH
Data for range was not collected, because analysis of median changes from baseline for laboratory parameters did not include range as part of the standard presentation per the statistical analysis plan.
|
PRIMARY outcome
Timeframe: Day 1 up to 85Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Participants with maximum changes from baseline (defined as increases or decreases of greater than or equal to \[≥\]20 mmHg or ≥30 mmHg) in either standing or supine systolic blood pressure (SBP) or diastolic blood pressure (DBP) measured in millimeters mercury (mmHg).
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
≥30 mmHg decrease from baseline in supine SBP
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
≥30 mmHg decrease from baseline in standing SBP
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
≥20 mmHg decrease from baseline in supine DBP
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
≥20 mmHg decrease from baseline in standing DBP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
≥30 mmHg increase from baseline in supine SBP
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
≥20 mmHg increase from baseline in supine DBP
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
≥20 mmHg increase from baseline in standing DBP
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Blood Pressure
≥30 mmHg increase from baseline in standing SBP
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 85Population: Safety Analysis Set: All participants who received at least 1 dose of study medication.
Participants with maximum changes from baseline (BSL) defined as: ≥25 to 50 percent (%) increase in maximum PR interval or QRS complex; increase from BSL of ≥30 milliseconds (msec) but \<60 msec in corrected QT (QTc) interval or QTcF interval (QTc interval corrected using Fridericia's correction); or increase from BSL ≥60 msec in either QTc interval or QTcF interval.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
≥25/50% increase from BSL in PR interval
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
≥25/50% increase from BSL in QRS complex
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
≥30 to <60 msec increase from BSL in QTc interval
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
≥60 msec increase from BSL in QTc interval
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
≥30 to <60 msec increase from BSL in QTcF interval
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal and Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
≥60 msec increase from BSL in QTcF interval
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Days -1, 8, 15, 29, 43, 57, and 85Population: Safety Analysis Population
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Day -1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Day 8
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Day 15
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Day 29
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Day 43
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Day 57
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADAs) by Study Visit
Day 85
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusionPopulation: Pharmacokinetic (PK) Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= number of participants evaluable for this outcome measure.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
1175 mcg*h/mL
Standard Deviation 197.79
|
7588 mcg*h/mL
Standard Deviation 1297.1
|
86360 mcg*h/mL
Standard Deviation 12846
|
348800 mcg*h/mL
Standard Deviation 43230
|
33960 mcg*h/mL
Standard Deviation 4326.5
|
171100 mcg*h/mL
Standard Deviation 12762
|
269600 mcg*h/mL
Standard Deviation 27289
|
—
|
SECONDARY outcome
Timeframe: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusionPopulation: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
9.580 mcg/mL
Standard Deviation 0.69545
|
29.20 mcg/mL
Standard Deviation 4.3353
|
205.8 mcg/mL
Standard Deviation 29.743
|
687.3 mcg/mL
Standard Deviation 69.032
|
92.05 mcg/mL
Standard Deviation 27.124
|
409.6 mcg/mL
Standard Deviation 56.592
|
549.4 mcg/mL
Standard Deviation 60.738
|
—
|
SECONDARY outcome
Timeframe: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusionPopulation: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax)
|
1.49 hours
Interval 1.0 to 4.0
|
2.05 hours
Interval 2.0 to 4.0
|
2.00 hours
Interval 1.12 to 4.0
|
2.00 hours
Interval 1.02 to 8.0
|
1.56 hours
Interval 1.08 to 72.0
|
2.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 2.0 to 4.03
|
—
|
SECONDARY outcome
Timeframe: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusionPopulation: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= 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 |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=2 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=3 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss)
|
NA mL
Standard Deviation NA
Vss could not be calculated for the 0.3 mg/kg dose since as per plan, reporting criteria for t1/2 were not met. The mean t1/2 could not be determined for the 0.3 mg/kg dose as the duration of sampling relative to the projected t1/2 was too short.
|
3817 mL
Standard Deviation 601.08
|
3511 mL
Standard Deviation 517.52
|
NA mL
Standard Deviation NA
Summary statistics were not calculated if fewer than 3 participants had reportable parameter values, as pre-specified.
|
3822 mL
Standard Deviation 657.59
|
3782 mL
Standard Deviation 703.64
|
4063 mL
Standard Deviation 291.03
|
—
|
SECONDARY outcome
Timeframe: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusionPopulation: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= number of participants evaluable for this outcome measure and "0" in the "overall number of participants analyzed" signifies that data not collected because none of the participants were evaluable for the specified arm.
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=3 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Clearance (CL)
|
—
|
7.647 mL/hr
Standard Deviation 1.9804
|
4.011 mL/hr
Standard Deviation 0.72503
|
—
|
5.729 mL/hr
Standard Deviation 1.2399
|
4.248 mL/hr
Standard Deviation 0.77445
|
3.587 mL/hr
Standard Deviation 0.32146
|
—
|
SECONDARY outcome
Timeframe: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusionPopulation: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= number of participants evaluable for this outcome measure.
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=2 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=3 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2)
|
NA hours
Standard Deviation NA
The mean t1/2 could not be determined for the 0.3 mg/kg dose range as the duration of sampling relative to the projected t1/2 was too short.
|
358.7 hours
Standard Deviation 50.603
|
637.8 hours
Standard Deviation 110.06
|
NA hours
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.
|
486.9 hours
Standard Deviation 92.644
|
657.5 hours
Standard Deviation 88.686
|
829.0 hours
Standard Deviation 82.286
|
—
|
SECONDARY outcome
Timeframe: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusionPopulation: PK Parameter Analysis Set: All enrolled participants treated who had at least 1 of the PK parameters of interest. Here, "overall number of participants analyzed"= number of participants evaluable for this outcome measure.
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=2 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=3 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]
|
NA mcg*h/mL
Standard Deviation NA
AUC(0-inf) could not be calculated for the 0.3 mg/kg dose since reporting criteria for t1/2 were not met. The mean t1/2 could not be determined for the 0.3 mg/kg dose range as the duration of sampling relative to the projected t1/2 was too short.
|
8655 mcg*h/mL
Standard Deviation 1390.4
|
97010 mcg*h/mL
Standard Deviation 18085
|
NA mcg*h/mL
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.
|
36270 mcg*h/mL
Standard Deviation 5387.0
|
192600 mcg*h/mL
Standard Deviation 13512
|
323800 mcg*h/mL
Standard Deviation 34395
|
—
|
SECONDARY outcome
Timeframe: Day 1 prior to infusion, 1, 2, 4, 8 and 12 hours and anytime on Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85 post-infusionPopulation: Based on internal clinical pharmacology guidance on the most appropriate parameter calculations for this study design, Vz/F was not reported. Instead, Vss was reported.
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 serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Based on internal clinical pharmacology guidance on the most appropriate parameter calculations for this study design, data for Vz/F was not collected instead Vss was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day -1, Day 1 (predose and at end of infusion) and at 2, 4, 8, and 12 hours postdose, and Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57, and 85Population: Pharmacodynamic (PD) Analysis Population: all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter in at least 1 treatment period. Analytical qualification of a total DKK-1 assay was unsuccessful, thus no data was collected and reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Days -1, 1), Days 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85Population: Pharmacodynamic (PD) Analysis Population: all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter in at least 1 treatment period; number analyzed=number of participants with an observation at the specified timepoints.
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 3
|
7.908 percentage change from baseline
Standard Deviation 10.3904
|
3.745 percentage change from baseline
Standard Deviation 8.0952
|
10.157 percentage change from baseline
Standard Deviation 11.1075
|
8.461 percentage change from baseline
Standard Deviation 13.9663
|
10.031 percentage change from baseline
Standard Deviation 9.2134
|
11.711 percentage change from baseline
Standard Deviation 18.7964
|
-3.213 percentage change from baseline
Standard Deviation 18.3073
|
4.963 percentage change from baseline
Standard Deviation 8.9468
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 4
|
2.361 percentage change from baseline
Standard Deviation 16.5524
|
-2.066 percentage change from baseline
Standard Deviation 6.7705
|
13.967 percentage change from baseline
Standard Deviation 17.9202
|
4.075 percentage change from baseline
Standard Deviation 5.5816
|
5.244 percentage change from baseline
Standard Deviation 8.4819
|
3.903 percentage change from baseline
Standard Deviation 11.3291
|
-9.057 percentage change from baseline
Standard Deviation 18.0136
|
-4.193 percentage change from baseline
Standard Deviation 9.1093
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 8
|
12.199 percentage change from baseline
Standard Deviation 20.7265
|
10.321 percentage change from baseline
Standard Deviation 10.8772
|
21.394 percentage change from baseline
Standard Deviation 20.6158
|
0.617 percentage change from baseline
Standard Deviation 8.3882
|
10.897 percentage change from baseline
Standard Deviation 20.3196
|
7.777 percentage change from baseline
Standard Deviation 16.0762
|
6.055 percentage change from baseline
Standard Deviation 12.4378
|
-0.979 percentage change from baseline
Standard Deviation 9.7628
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 22
|
5.155 percentage change from baseline
Standard Deviation 14.1736
|
12.822 percentage change from baseline
Standard Deviation 9.7902
|
36.693 percentage change from baseline
Standard Deviation 29.1840
|
13.739 percentage change from baseline
Standard Deviation 13.9117
|
24.114 percentage change from baseline
Standard Deviation 20.7782
|
11.211 percentage change from baseline
Standard Deviation 13.9796
|
11.284 percentage change from baseline
Standard Deviation 13.1751
|
-0.132 percentage change from baseline
Standard Deviation 9.1245
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 29
|
2.579 percentage change from baseline
Standard Deviation 16.2957
|
5.117 percentage change from baseline
Standard Deviation 9.1142
|
23.742 percentage change from baseline
Standard Deviation 18.7153
|
16.135 percentage change from baseline
Standard Deviation 13.1185
|
26.118 percentage change from baseline
Standard Deviation 22.8948
|
12.405 percentage change from baseline
Standard Deviation 15.4178
|
10.753 percentage change from baseline
Standard Deviation 16.1139
|
-6.509 percentage change from baseline
Standard Deviation 24.9432
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 36
|
-3.344 percentage change from baseline
Standard Deviation 17.0168
|
13.737 percentage change from baseline
Standard Deviation 10.2997
|
32.558 percentage change from baseline
Standard Deviation 50.4404
|
7.649 percentage change from baseline
Standard Deviation 18.2140
|
25.180 percentage change from baseline
Standard Deviation 18.4425
|
7.855 percentage change from baseline
Standard Deviation 11.6990
|
13.370 percentage change from baseline
Standard Deviation 17.6498
|
1.941 percentage change from baseline
Standard Deviation 12.6475
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 43
|
-1.986 percentage change from baseline
Standard Deviation 15.4137
|
-17.799 percentage change from baseline
Standard Deviation 44.2793
|
19.420 percentage change from baseline
Standard Deviation 42.2273
|
0.720 percentage change from baseline
Standard Deviation 9.3270
|
28.914 percentage change from baseline
Standard Deviation 27.3598
|
10.576 percentage change from baseline
Standard Deviation 15.4128
|
12.696 percentage change from baseline
Standard Deviation 19.6629
|
1.210 percentage change from baseline
Standard Deviation 17.0653
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 57
|
0.105 percentage change from baseline
Standard Deviation 26.5164
|
5.225 percentage change from baseline
Standard Deviation 14.3348
|
27.459 percentage change from baseline
Standard Deviation 60.2028
|
-6.992 percentage change from baseline
Standard Deviation 20.6680
|
23.830 percentage change from baseline
Standard Deviation 28.0126
|
3.594 percentage change from baseline
Standard Deviation 23.5914
|
4.568 percentage change from baseline
Standard Deviation 21.1743
|
-2.427 percentage change from baseline
Standard Deviation 12.3301
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 85
|
-7.489 percentage change from baseline
Standard Deviation 9.5892
|
-4.566 percentage change from baseline
Standard Deviation 5.8947
|
37.825 percentage change from baseline
Standard Deviation 35.2720
|
5.423 percentage change from baseline
Standard Deviation 17.8942
|
22.304 percentage change from baseline
Standard Deviation 29.7686
|
1.623 percentage change from baseline
Standard Deviation 19.8165
|
-2.263 percentage change from baseline
Standard Deviation 22.4866
|
0.820 percentage change from baseline
Standard Deviation 14.4801
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 2
|
0.161 percentage change from baseline
Standard Deviation 6.9455
|
2.836 percentage change from baseline
Standard Deviation 6.4467
|
11.237 percentage change from baseline
Standard Deviation 16.8782
|
5.894 percentage change from baseline
Standard Deviation 10.8227
|
2.366 percentage change from baseline
Standard Deviation 5.9293
|
2.238 percentage change from baseline
Standard Deviation 9.8233
|
-1.626 percentage change from baseline
Standard Deviation 11.2516
|
3.005 percentage change from baseline
Standard Deviation 6.4941
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 5
|
8.794 percentage change from baseline
Standard Deviation 15.6171
|
-2.352 percentage change from baseline
Standard Deviation 10.5552
|
7.884 percentage change from baseline
Standard Deviation 26.1801
|
5.535 percentage change from baseline
Standard Deviation 9.2328
|
12.242 percentage change from baseline
Standard Deviation 14.1055
|
5.619 percentage change from baseline
Standard Deviation 12.2245
|
-12.708 percentage change from baseline
Standard Deviation 17.0940
|
-3.344 percentage change from baseline
Standard Deviation 12.6299
|
|
Mean Percentage Change From Baseline in Serum Procollagen Type 1 Amino-Terminal Propeptide (PINP) (ng/mL) Over Time
Day 15
|
8.524 percentage change from baseline
Standard Deviation 8.3551
|
7.618 percentage change from baseline
Standard Deviation 17.3215
|
28.710 percentage change from baseline
Standard Deviation 33.2390
|
12.031 percentage change from baseline
Standard Deviation 14.0186
|
9.904 percentage change from baseline
Standard Deviation 13.0457
|
15.259 percentage change from baseline
Standard Deviation 12.3700
|
9.717 percentage change from baseline
Standard Deviation 18.5300
|
-0.968 percentage change from baseline
Standard Deviation 14.1064
|
SECONDARY outcome
Timeframe: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 3
|
-17.167 percentage change from baseline
Standard Deviation 5.7802
|
-1.748 percentage change from baseline
Standard Deviation 13.3302
|
2.418 percentage change from baseline
Standard Deviation 31.5323
|
13.956 percentage change from baseline
Standard Deviation 19.3949
|
0.893 percentage change from baseline
Standard Deviation 28.3001
|
4.121 percentage change from baseline
Standard Deviation 20.9339
|
18.209 percentage change from baseline
Standard Deviation 38.3564
|
-4.200 percentage change from baseline
Standard Deviation 29.1776
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 4
|
-9.634 percentage change from baseline
Standard Deviation 9.5923
|
4.448 percentage change from baseline
Standard Deviation 18.3997
|
7.293 percentage change from baseline
Standard Deviation 24.6717
|
15.841 percentage change from baseline
Standard Deviation 23.4485
|
2.337 percentage change from baseline
Standard Deviation 24.1029
|
-0.774 percentage change from baseline
Standard Deviation 42.0609
|
13.921 percentage change from baseline
Standard Deviation 27.0459
|
4.847 percentage change from baseline
Standard Deviation 22.2872
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 5
|
2.826 percentage change from baseline
Standard Deviation 11.4062
|
8.577 percentage change from baseline
Standard Deviation 13.4307
|
18.005 percentage change from baseline
Standard Deviation 18.1277
|
17.300 percentage change from baseline
Standard Deviation 28.7024
|
5.471 percentage change from baseline
Standard Deviation 6.9326
|
-2.630 percentage change from baseline
Standard Deviation 42.6402
|
0.658 percentage change from baseline
Standard Deviation 22.0426
|
7.604 percentage change from baseline
Standard Deviation 18.3770
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 8
|
5.301 percentage change from baseline
Standard Deviation 9.8120
|
8.608 percentage change from baseline
Standard Deviation 11.9505
|
6.474 percentage change from baseline
Standard Deviation 20.9251
|
25.846 percentage change from baseline
Standard Deviation 41.5938
|
3.453 percentage change from baseline
Standard Deviation 23.3280
|
16.222 percentage change from baseline
Standard Deviation 23.3731
|
-7.186 percentage change from baseline
Standard Deviation 12.9910
|
5.801 percentage change from baseline
Standard Deviation 19.8534
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 15
|
-7.765 percentage change from baseline
Standard Deviation 4.8847
|
-11.284 percentage change from baseline
Standard Deviation 10.8652
|
-1.807 percentage change from baseline
Standard Deviation 13.4761
|
10.608 percentage change from baseline
Standard Deviation 17.0266
|
-13.589 percentage change from baseline
Standard Deviation 37.8165
|
-1.536 percentage change from baseline
Standard Deviation 27.2663
|
-17.954 percentage change from baseline
Standard Deviation 36.9722
|
-11.942 percentage change from baseline
Standard Deviation 13.2393
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 22
|
-0.445 percentage change from baseline
Standard Deviation 22.3404
|
15.509 percentage change from baseline
Standard Deviation 33.1029
|
6.389 percentage change from baseline
Standard Deviation 13.9819
|
18.665 percentage change from baseline
Standard Deviation 28.1286
|
11.789 percentage change from baseline
Standard Deviation 26.3816
|
1.645 percentage change from baseline
Standard Deviation 27.2237
|
-3.770 percentage change from baseline
Standard Deviation 12.9370
|
7.018 percentage change from baseline
Standard Deviation 36.6005
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 36
|
-3.067 percentage change from baseline
Standard Deviation 17.7754
|
3.234 percentage change from baseline
Standard Deviation 24.2622
|
12.494 percentage change from baseline
Standard Deviation 12.9419
|
3.576 percentage change from baseline
Standard Deviation 15.1739
|
26.179 percentage change from baseline
Standard Deviation 24.2615
|
8.340 percentage change from baseline
Standard Deviation 33.1330
|
-3.981 percentage change from baseline
Standard Deviation 20.5915
|
6.048 percentage change from baseline
Standard Deviation 31.9348
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 43
|
-7.690 percentage change from baseline
Standard Deviation 21.3058
|
-3.596 percentage change from baseline
Standard Deviation 12.5937
|
0.833 percentage change from baseline
Standard Deviation 16.6770
|
14.111 percentage change from baseline
Standard Deviation 23.1987
|
25.679 percentage change from baseline
Standard Deviation 36.1569
|
13.512 percentage change from baseline
Standard Deviation 32.4953
|
-1.915 percentage change from baseline
Standard Deviation 20.7555
|
0.609 percentage change from baseline
Standard Deviation 20.9022
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 57
|
2.287 percentage change from baseline
Standard Deviation 20.6325
|
9.131 percentage change from baseline
Standard Deviation 14.1892
|
12.259 percentage change from baseline
Standard Deviation 18.8943
|
20.932 percentage change from baseline
Standard Deviation 22.0040
|
25.024 percentage change from baseline
Standard Deviation 33.4126
|
20.849 percentage change from baseline
Standard Deviation 62.3389
|
-25.654 percentage change from baseline
Standard Deviation 35.7350
|
-0.175 percentage change from baseline
Standard Deviation 24.4156
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 85
|
5.677 percentage change from baseline
Standard Deviation 6.5738
|
14.354 percentage change from baseline
Standard Deviation 33.2027
|
-3.162 percentage change from baseline
Standard Deviation 56.6723
|
20.327 percentage change from baseline
Standard Deviation 24.8686
|
12.477 percentage change from baseline
Standard Deviation 31.9743
|
7.108 percentage change from baseline
Standard Deviation 37.6896
|
-5.121 percentage change from baseline
Standard Deviation 13.1626
|
1.615 percentage change from baseline
Standard Deviation 20.9010
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 2
|
-4.602 percentage change from baseline
Standard Deviation 14.2023
|
-6.789 percentage change from baseline
Standard Deviation 9.8119
|
-1.247 percentage change from baseline
Standard Deviation 19.0705
|
19.637 percentage change from baseline
Standard Deviation 13.9540
|
-3.399 percentage change from baseline
Standard Deviation 21.0488
|
-4.220 percentage change from baseline
Standard Deviation 39.6859
|
-1.659 percentage change from baseline
Standard Deviation 19.1445
|
-7.860 percentage change from baseline
Standard Deviation 16.6291
|
|
Mean Percentage Change From Baseline in Serum n-Terminal Telopeptide(NTX) Over Time
Day 29
|
-0.026 percentage change from baseline
Standard Deviation 19.4086
|
-4.254 percentage change from baseline
Standard Deviation 17.2335
|
17.712 percentage change from baseline
Standard Deviation 10.5885
|
33.244 percentage change from baseline
Standard Deviation 19.9530
|
7.721 percentage change from baseline
Standard Deviation 39.3020
|
11.095 percentage change from baseline
Standard Deviation 32.3792
|
0.979 percentage change from baseline
Standard Deviation 26.2735
|
5.779 percentage change from baseline
Standard Deviation 27.5110
|
SECONDARY outcome
Timeframe: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 2
|
3.467 percentage change
Standard Deviation 7.6528
|
6.218 percentage change
Standard Deviation 19.6492
|
26.444 percentage change
Standard Deviation 16.5991
|
9.644 percentage change
Standard Deviation 6.9192
|
0.024 percentage change
Standard Deviation 14.1443
|
4.756 percentage change
Standard Deviation 16.3268
|
7.585 percentage change
Standard Deviation 8.7674
|
2.372 percentage change
Standard Deviation 27.8091
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 3
|
-4.472 percentage change
Standard Deviation 7.9083
|
4.296 percentage change
Standard Deviation 15.1105
|
16.416 percentage change
Standard Deviation 6.2517
|
11.628 percentage change
Standard Deviation 9.2015
|
-0.980 percentage change
Standard Deviation 17.3430
|
6.211 percentage change
Standard Deviation 24.1040
|
14.878 percentage change
Standard Deviation 17.6179
|
9.334 percentage change
Standard Deviation 15.7981
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 4
|
-10.411 percentage change
Standard Deviation 13.5145
|
1.482 percentage change
Standard Deviation 14.9042
|
15.999 percentage change
Standard Deviation 18.0461
|
-0.529 percentage change
Standard Deviation 14.2914
|
-5.354 percentage change
Standard Deviation 25.1017
|
-14.378 percentage change
Standard Deviation 12.3489
|
3.407 percentage change
Standard Deviation 20.9937
|
7.499 percentage change
Standard Deviation 15.6537
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 5
|
-8.039 percentage change
Standard Deviation 9.8536
|
8.380 percentage change
Standard Deviation 20.4009
|
9.864 percentage change
Standard Deviation 20.1860
|
-0.322 percentage change
Standard Deviation 8.0655
|
0.462 percentage change
Standard Deviation 27.4688
|
-6.551 percentage change
Standard Deviation 16.7397
|
11.802 percentage change
Standard Deviation 25.1567
|
3.983 percentage change
Standard Deviation 20.4928
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 8
|
-9.424 percentage change
Standard Deviation 10.3618
|
-8.866 percentage change
Standard Deviation 19.8682
|
8.572 percentage change
Standard Deviation 24.7327
|
-6.834 percentage change
Standard Deviation 9.6209
|
-8.233 percentage change
Standard Deviation 31.2067
|
-5.499 percentage change
Standard Deviation 21.6249
|
-6.296 percentage change
Standard Deviation 17.1832
|
1.488 percentage change
Standard Deviation 15.6940
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 15
|
-12.864 percentage change
Standard Deviation 9.2562
|
-7.907 percentage change
Standard Deviation 8.5077
|
24.010 percentage change
Standard Deviation 20.2593
|
-2.931 percentage change
Standard Deviation 10.3678
|
-12.009 percentage change
Standard Deviation 14.0871
|
-4.800 percentage change
Standard Deviation 14.0773
|
-4.586 percentage change
Standard Deviation 19.8401
|
7.668 percentage change
Standard Deviation 19.2344
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 22
|
-9.972 percentage change
Standard Deviation 14.6179
|
-8.980 percentage change
Standard Deviation 16.1776
|
25.799 percentage change
Standard Deviation 20.0022
|
-17.477 percentage change
Standard Deviation 9.9364
|
-10.414 percentage change
Standard Deviation 10.1372
|
-12.078 percentage change
Standard Deviation 17.7073
|
-4.843 percentage change
Standard Deviation 14.4791
|
12.395 percentage change
Standard Deviation 42.6940
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 85
|
-5.989 percentage change
Standard Deviation 16.6472
|
-5.584 percentage change
Standard Deviation 19.4223
|
33.724 percentage change
Standard Deviation 44.0981
|
-14.097 percentage change
Standard Deviation 18.5865
|
-4.368 percentage change
Standard Deviation 22.8715
|
-12.647 percentage change
Standard Deviation 15.1312
|
-9.104 percentage change
Standard Deviation 18.4964
|
2.521 percentage change
Standard Deviation 18.3823
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 29
|
-6.741 percentage change
Standard Deviation 8.4135
|
-11.367 percentage change
Standard Deviation 8.0673
|
27.694 percentage change
Standard Deviation 23.7259
|
1.130 percentage change
Standard Deviation 15.5004
|
-19.376 percentage change
Standard Deviation 15.1382
|
-3.761 percentage change
Standard Deviation 17.8403
|
-5.356 percentage change
Standard Deviation 22.7410
|
2.626 percentage change
Standard Deviation 16.7445
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 36
|
4.934 percentage change
Standard Deviation 19.2980
|
-14.092 percentage change
Standard Deviation 14.6006
|
26.589 percentage change
Standard Deviation 18.1507
|
-9.145 percentage change
Standard Deviation 22.6658
|
-13.549 percentage change
Standard Deviation 16.1342
|
-6.819 percentage change
Standard Deviation 30.2060
|
2.090 percentage change
Standard Deviation 15.8885
|
1.337 percentage change
Standard Deviation 21.1947
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 43
|
-9.903 percentage change
Standard Deviation 18.8829
|
0.422 percentage change
Standard Deviation 11.8856
|
18.554 percentage change
Standard Deviation 33.9325
|
-8.871 percentage change
Standard Deviation 19.2661
|
-1.681 percentage change
Standard Deviation 19.1395
|
-8.608 percentage change
Standard Deviation 17.6558
|
5.776 percentage change
Standard Deviation 12.9204
|
1.531 percentage change
Standard Deviation 14.7672
|
|
Mean Percentage Change From Baseline in Serum Carboxy (C) Terminal Telopeptide (CTX) Over Time
Day 57
|
1.090 percentage change
Standard Deviation 16.2461
|
-1.360 percentage change
Standard Deviation 11.7081
|
13.993 percentage change
Standard Deviation 17.1176
|
-13.721 percentage change
Standard Deviation 13.0090
|
3.519 percentage change
Standard Deviation 29.4764
|
-7.134 percentage change
Standard Deviation 28.0770
|
-10.254 percentage change
Standard Deviation 16.1050
|
2.932 percentage change
Standard Deviation 23.9281
|
SECONDARY outcome
Timeframe: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 2
|
-6.185 percentage change
Standard Deviation 6.3059
|
-2.849 percentage change
Standard Deviation 3.8567
|
-0.796 percentage change
Standard Deviation 7.4823
|
-7.570 percentage change
Standard Deviation 9.2328
|
-0.796 percentage change
Standard Deviation 3.6143
|
-6.334 percentage change
Standard Deviation 7.9459
|
-3.927 percentage change
Standard Deviation 5.4622
|
-3.934 percentage change
Standard Deviation 7.4244
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 3
|
-4.280 percentage change
Standard Deviation 9.5383
|
0.331 percentage change
Standard Deviation 6.4424
|
4.848 percentage change
Standard Deviation 10.6591
|
0.125 percentage change
Standard Deviation 7.8541
|
0.160 percentage change
Standard Deviation 7.3513
|
-7.289 percentage change
Standard Deviation 5.5333
|
-4.873 percentage change
Standard Deviation 14.7151
|
-3.010 percentage change
Standard Deviation 8.1557
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 4
|
0.929 percentage change
Standard Deviation 8.4449
|
0.729 percentage change
Standard Deviation 5.9355
|
5.189 percentage change
Standard Deviation 8.7365
|
2.074 percentage change
Standard Deviation 9.4077
|
2.460 percentage change
Standard Deviation 5.9179
|
0.052 percentage change
Standard Deviation 6.5211
|
-2.325 percentage change
Standard Deviation 16.0997
|
-0.876 percentage change
Standard Deviation 7.4064
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 5
|
1.621 percentage change
Standard Deviation 11.3210
|
2.592 percentage change
Standard Deviation 6.4759
|
1.767 percentage change
Standard Deviation 8.0676
|
0.313 percentage change
Standard Deviation 3.9781
|
0.038 percentage change
Standard Deviation 5.5704
|
-2.158 percentage change
Standard Deviation 10.6419
|
-4.115 percentage change
Standard Deviation 16.0237
|
-0.124 percentage change
Standard Deviation 10.4404
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 8
|
6.038 percentage change
Standard Deviation 4.8726
|
7.438 percentage change
Standard Deviation 7.8948
|
6.823 percentage change
Standard Deviation 9.1449
|
5.260 percentage change
Standard Deviation 9.7094
|
0.558 percentage change
Standard Deviation 8.7457
|
2.468 percentage change
Standard Deviation 12.5723
|
-0.332 percentage change
Standard Deviation 13.5092
|
-0.594 percentage change
Standard Deviation 10.8209
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 22
|
19.200 percentage change
Standard Deviation 6.8095
|
15.884 percentage change
Standard Deviation 17.1866
|
4.513 percentage change
Standard Deviation 12.9814
|
9.570 percentage change
Standard Deviation 11.1603
|
3.469 percentage change
Standard Deviation 15.0685
|
-2.533 percentage change
Standard Deviation 7.4853
|
2.937 percentage change
Standard Deviation 13.2892
|
-2.589 percentage change
Standard Deviation 14.3755
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 29
|
17.180 percentage change
Standard Deviation 7.2047
|
17.688 percentage change
Standard Deviation 18.6277
|
4.684 percentage change
Standard Deviation 14.0010
|
13.649 percentage change
Standard Deviation 7.9592
|
-1.368 percentage change
Standard Deviation 16.3976
|
-0.313 percentage change
Standard Deviation 14.4515
|
3.230 percentage change
Standard Deviation 16.5615
|
-4.472 percentage change
Standard Deviation 15.3127
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 36
|
12.815 percentage change
Standard Deviation 7.1986
|
10.798 percentage change
Standard Deviation 16.4632
|
9.205 percentage change
Standard Deviation 15.8163
|
9.652 percentage change
Standard Deviation 6.5596
|
7.952 percentage change
Standard Deviation 10.8748
|
-0.917 percentage change
Standard Deviation 14.9214
|
1.002 percentage change
Standard Deviation 12.9844
|
-0.863 percentage change
Standard Deviation 13.2753
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 43
|
3.622 percentage change
Standard Deviation 5.8263
|
11.610 percentage change
Standard Deviation 14.5871
|
10.813 percentage change
Standard Deviation 12.7424
|
9.018 percentage change
Standard Deviation 8.0671
|
8.902 percentage change
Standard Deviation 16.7039
|
0.731 percentage change
Standard Deviation 11.6516
|
5.795 percentage change
Standard Deviation 15.4580
|
0.977 percentage change
Standard Deviation 13.0563
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 57
|
6.766 percentage change
Standard Deviation 4.2535
|
0.848 percentage change
Standard Deviation 15.5889
|
7.169 percentage change
Standard Deviation 19.2122
|
0.851 percentage change
Standard Deviation 18.5419
|
9.197 percentage change
Standard Deviation 19.9274
|
-10.431 percentage change
Standard Deviation 14.3542
|
0.676 percentage change
Standard Deviation 16.3864
|
0.155 percentage change
Standard Deviation 11.9164
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 15
|
11.455 percentage change
Standard Deviation 7.6760
|
6.526 percentage change
Standard Deviation 6.5755
|
6.179 percentage change
Standard Deviation 9.1027
|
10.983 percentage change
Standard Deviation 10.9069
|
3.291 percentage change
Standard Deviation 9.4929
|
4.573 percentage change
Standard Deviation 9.0742
|
0.048 percentage change
Standard Deviation 8.8057
|
-5.780 percentage change
Standard Deviation 12.2364
|
|
Mean Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) Over Time
Day 85
|
8.418 percentage change
Standard Deviation 9.2449
|
-0.234 percentage change
Standard Deviation 8.3530
|
7.156 percentage change
Standard Deviation 8.6010
|
8.344 percentage change
Standard Deviation 5.4401
|
13.720 percentage change
Standard Deviation 17.5660
|
-5.825 percentage change
Standard Deviation 16.8764
|
7.332 percentage change
Standard Deviation 12.0581
|
3.076 percentage change
Standard Deviation 13.2167
|
SECONDARY outcome
Timeframe: Days -1, 1 (predose), 2, 3, 4, 5, 8, 15, 22, 29, 36, 43, 57 and 85Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
Baseline calculated as average of Day -1 and Day 1 prior to infusion of PF-04840082
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 29
|
11.576 percentage change
Standard Deviation 9.6497
|
5.871 percentage change
Standard Deviation 10.3258
|
18.627 percentage change
Standard Deviation 11.5843
|
10.099 percentage change
Standard Deviation 10.8958
|
1.437 percentage change
Standard Deviation 6.4453
|
9.743 percentage change
Standard Deviation 16.1027
|
2.127 percentage change
Standard Deviation 8.3314
|
3.921 percentage change
Standard Deviation 12.1504
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 2
|
5.734 percentage change
Standard Deviation 14.0949
|
1.688 percentage change
Standard Deviation 11.1780
|
4.798 percentage change
Standard Deviation 8.2785
|
0.635 percentage change
Standard Deviation 10.1481
|
0.663 percentage change
Standard Deviation 8.3158
|
-3.061 percentage change
Standard Deviation 12.9637
|
-10.946 percentage change
Standard Deviation 16.5586
|
1.936 percentage change
Standard Deviation 9.1701
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 3
|
4.252 percentage change
Standard Deviation 5.9602
|
-2.471 percentage change
Standard Deviation 10.0364
|
3.026 percentage change
Standard Deviation 6.6556
|
-0.209 percentage change
Standard Deviation 5.4522
|
3.157 percentage change
Standard Deviation 6.2435
|
-3.711 percentage change
Standard Deviation 9.1520
|
-7.423 percentage change
Standard Deviation 21.8432
|
3.742 percentage change
Standard Deviation 8.6378
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 4
|
4.801 percentage change
Standard Deviation 15.6593
|
2.092 percentage change
Standard Deviation 13.5746
|
10.000 percentage change
Standard Deviation 11.8129
|
0.230 percentage change
Standard Deviation 8.3494
|
3.189 percentage change
Standard Deviation 12.2261
|
-3.261 percentage change
Standard Deviation 14.2519
|
-0.178 percentage change
Standard Deviation 14.0562
|
2.626 percentage change
Standard Deviation 9.7866
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 5
|
6.641 percentage change
Standard Deviation 18.8735
|
4.175 percentage change
Standard Deviation 9.7966
|
1.586 percentage change
Standard Deviation 10.7697
|
7.592 percentage change
Standard Deviation 12.0591
|
6.756 percentage change
Standard Deviation 6.3289
|
-0.848 percentage change
Standard Deviation 16.4937
|
-3.098 percentage change
Standard Deviation 11.1147
|
1.747 percentage change
Standard Deviation 9.4714
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 8
|
8.822 percentage change
Standard Deviation 22.5890
|
2.271 percentage change
Standard Deviation 9.4185
|
11.110 percentage change
Standard Deviation 6.1704
|
-2.724 percentage change
Standard Deviation 8.4175
|
-1.473 percentage change
Standard Deviation 7.9618
|
4.143 percentage change
Standard Deviation 16.5179
|
2.020 percentage change
Standard Deviation 8.1968
|
0.468 percentage change
Standard Deviation 9.2202
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 15
|
4.055 percentage change
Standard Deviation 17.6355
|
3.056 percentage change
Standard Deviation 15.1080
|
12.216 percentage change
Standard Deviation 14.1642
|
1.975 percentage change
Standard Deviation 15.1871
|
4.501 percentage change
Standard Deviation 7.0609
|
3.062 percentage change
Standard Deviation 10.4890
|
0.989 percentage change
Standard Deviation 10.4834
|
3.223 percentage change
Standard Deviation 10.0156
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 22
|
13.219 percentage change
Standard Deviation 12.8986
|
5.755 percentage change
Standard Deviation 8.6481
|
29.785 percentage change
Standard Deviation 19.5030
|
4.503 percentage change
Standard Deviation 9.3465
|
5.338 percentage change
Standard Deviation 7.8661
|
3.025 percentage change
Standard Deviation 11.8149
|
1.945 percentage change
Standard Deviation 5.9013
|
5.407 percentage change
Standard Deviation 9.6448
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 36
|
14.208 percentage change
Standard Deviation 21.3667
|
9.358 percentage change
Standard Deviation 5.7878
|
20.845 percentage change
Standard Deviation 19.4756
|
6.917 percentage change
Standard Deviation 16.2552
|
2.365 percentage change
Standard Deviation 5.0844
|
8.089 percentage change
Standard Deviation 14.6337
|
4.071 percentage change
Standard Deviation 8.5288
|
1.356 percentage change
Standard Deviation 13.0154
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 43
|
6.087 percentage change
Standard Deviation 10.9388
|
8.222 percentage change
Standard Deviation 8.0005
|
8.185 percentage change
Standard Deviation 13.8026
|
3.429 percentage change
Standard Deviation 12.8258
|
8.281 percentage change
Standard Deviation 12.6603
|
7.902 percentage change
Standard Deviation 9.1879
|
4.218 percentage change
Standard Deviation 6.6123
|
1.908 percentage change
Standard Deviation 17.3185
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 57
|
6.934 percentage change
Standard Deviation 12.8116
|
5.128 percentage change
Standard Deviation 10.0036
|
15.296 percentage change
Standard Deviation 36.6778
|
-9.431 percentage change
Standard Deviation 15.5609
|
7.814 percentage change
Standard Deviation 19.6299
|
12.055 percentage change
Standard Deviation 27.4156
|
-0.711 percentage change
Standard Deviation 11.7627
|
1.672 percentage change
Standard Deviation 12.3701
|
|
Mean Percentage Change From Baseline in Serum Osteocalcin Over Time
Day 85
|
5.766 percentage change
Standard Deviation 12.8626
|
-7.261 percentage change
Standard Deviation 8.1118
|
30.350 percentage change
Standard Deviation 24.3439
|
6.667 percentage change
Standard Deviation 15.6370
|
2.338 percentage change
Standard Deviation 18.2941
|
0.554 percentage change
Standard Deviation 12.1071
|
-2.414 percentage change
Standard Deviation 17.1454
|
1.329 percentage change
Standard Deviation 14.3518
|
SECONDARY outcome
Timeframe: Days -1 and 85Population: PD Analysis Population; number analyzed=number of participants with an observation at the specified timepoints.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
AP Spine L1 BMD
|
-4.096 percentage change
Standard Deviation 7.5769
|
3.820 percentage change
Standard Deviation 2.8253
|
-0.725 percentage change
Standard Deviation 2.8558
|
-1.377 percentage change
Standard Deviation 6.5000
|
0.437 percentage change
Standard Deviation 6.1468
|
-0.305 percentage change
Standard Deviation 4.2402
|
-1.033 percentage change
Standard Deviation 3.4547
|
-0.439 percentage change
Standard Deviation 3.7668
|
|
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
AP Spine L2 BMD
|
-1.441 percentage change
Standard Deviation 6.4764
|
-0.816 percentage change
Standard Deviation 5.8942
|
0.454 percentage change
Standard Deviation 1.6845
|
-0.200 percentage change
Standard Deviation 8.7398
|
-0.940 percentage change
Standard Deviation 2.1560
|
-0.890 percentage change
Standard Deviation 5.0854
|
0.609 percentage change
Standard Deviation 3.8245
|
1.060 percentage change
Standard Deviation 3.9478
|
|
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
AP Spine L3 BMD
|
1.467 percentage change
Standard Deviation 5.3680
|
-1.172 percentage change
Standard Deviation 6.4637
|
0.237 percentage change
Standard Deviation 3.0146
|
-3.332 percentage change
Standard Deviation 4.5817
|
0.942 percentage change
Standard Deviation 2.8890
|
0.973 percentage change
Standard Deviation 5.3894
|
0.793 percentage change
Standard Deviation 4.8739
|
-1.330 percentage change
Standard Deviation 3.1723
|
|
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
AP Spine L4 BMD
|
-1.908 percentage change
Standard Deviation 4.7541
|
2.443 percentage change
Standard Deviation 6.4076
|
-1.553 percentage change
Standard Deviation 3.7424
|
1.228 percentage change
Standard Deviation 7.7207
|
-0.171 percentage change
Standard Deviation 3.6823
|
0.470 percentage change
Standard Deviation 5.2763
|
0.171 percentage change
Standard Deviation 3.7706
|
-1.288 percentage change
Standard Deviation 3.6274
|
|
Mean Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
AP Spine Total L1-L4 BMD
|
-1.356 percentage change
Standard Deviation 3.3947
|
0.975 percentage change
Standard Deviation 4.5713
|
-0.914 percentage change
Standard Deviation 2.2948
|
-0.918 percentage change
Standard Deviation 5.8689
|
0.144 percentage change
Standard Deviation 2.1232
|
0.095 percentage change
Standard Deviation 3.4250
|
0.206 percentage change
Standard Deviation 3.2457
|
-0.794 percentage change
Standard Deviation 2.2182
|
SECONDARY outcome
Timeframe: Day 85Population: PD Analysis Population. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
BMD was evaluated by dual energy X-ray absorptiometry (DXA).
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=5 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=18 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Femoral Neck BMD at Day 85
|
0.7308 Gram per centimeter square
Standard Deviation 0.09688
|
0.8357 Gram per centimeter square
Standard Deviation 0.09877
|
0.8135 Gram per centimeter square
Standard Deviation 0.10100
|
0.7954 Gram per centimeter square
Standard Deviation 0.10295
|
0.8666 Gram per centimeter square
Standard Deviation 0.11867
|
0.7185 Gram per centimeter square
Standard Deviation 0.07402
|
0.8993 Gram per centimeter square
Standard Deviation 0.06102
|
0.8362 Gram per centimeter square
Standard Deviation 0.11301
|
SECONDARY outcome
Timeframe: Day 85Population: PD Analysis Population. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
BMD was evaluated by DXA. T-score was calculated based on actual measured bone density value and is the standardized scores that reflect the standard deviations (SDs) above/below the mean. A BMD T-score of -1.0 or more indicates normal bone density. T-score between -1.0 and -2.5 indicates low bone density known as osteopenia. A T-score of -2.5 or less is diagnostic of osteoporosis.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=5 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=18 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Femoral Neck T-Score at Day 85
|
-1.2833 T-score
Standard Deviation 0.81833
|
-0.7333 T-score
Standard Deviation 1.55906
|
-1.2833 T-score
Standard Deviation 0.36009
|
-1.7600 T-score
Standard Deviation 0.70922
|
-0.9324 T-score
Standard Deviation 1.14262
|
-1.6500 T-score
Standard Deviation 0.74066
|
-0.8466 T-score
Standard Deviation 0.73385
|
-1.2278 T-score
Standard Deviation 0.57477
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 85Population: PD Analysis Population; Here, Overall number of participants analyzed=number of participants evaluable for this outcome measure.
BMD was evaluated by DXA.
Outcome measures
| Measure |
PF-04840082 0.3 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=5 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=5 Participants
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=7 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=17 Participants
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Distal Radius BMD at Day 85
Ulna BMD
|
-1.014 percentage change
Standard Deviation 4.1485
|
2.767 percentage change
Standard Deviation 6.7007
|
-0.760 percentage change
Standard Deviation 2.0682
|
3.131 percentage change
Standard Deviation 2.8903
|
1.207 percentage change
Standard Deviation 3.0197
|
-2.595 percentage change
Standard Deviation 2.6200
|
7.542 percentage change
Standard Deviation 7.5636
|
-1.101 percentage change
Standard Deviation 7.2397
|
|
Mean Percentage Change From Baseline in Distal Radius BMD at Day 85
Radius BMD
|
-0.138 percentage change
Standard Deviation 3.3241
|
1.673 percentage change
Standard Deviation 5.2845
|
-1.545 percentage change
Standard Deviation 3.8933
|
1.226 percentage change
Standard Deviation 2.5319
|
1.387 percentage change
Standard Deviation 3.3849
|
-1.223 percentage change
Standard Deviation 4.6806
|
6.485 percentage change
Standard Deviation 7.5097
|
-0.610 percentage change
Standard Deviation 6.6493
|
|
Mean Percentage Change From Baseline in Distal Radius BMD at Day 85
Forearm Total BMD
|
-8.608 percentage change
Standard Deviation 19.6096
|
0.716 percentage change
Standard Deviation 6.9188
|
-1.253 percentage change
Standard Deviation 3.0603
|
7.744 percentage change
Standard Deviation 13.4882
|
-0.823 percentage change
Standard Deviation 7.7854
|
-2.087 percentage change
Standard Deviation 2.1496
|
6.944 percentage change
Standard Deviation 6.4528
|
2.439 percentage change
Standard Deviation 12.9063
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Outcome measures
Outcome data not reported
Adverse Events
PF-04840082 0.3 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-04840082 1.0 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-04840082 6.0 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-04840082 24.0 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-04840082 3.0 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-04840082 12.0 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-04840082 18.0 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04840082 0.3 mg/kg
n=6 participants at risk
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 participants at risk
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 participants at risk
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 participants at risk
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 participants at risk
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 participants at risk
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 participants at risk
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 participants at risk
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Clostridium difficile colitis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 |
PF-04840082 0.3 mg/kg
n=6 participants at risk
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single intravenous (IV) infusion of PF-04840082 0.3 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 1.0 mg/kg
n=6 participants at risk
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 1.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 6.0 mg/kg
n=6 participants at risk
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 6.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 24.0 mg/kg
n=6 participants at risk
Healthy postmenopausal female participants with osteopenia between the ages of 55-80 years received a single IV infusion of PF-04840082 24.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 3.0 mg/kg
n=8 participants at risk
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 3.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 12.0 mg/kg
n=8 participants at risk
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 12.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
PF-04840082 18.0 mg/kg
n=8 participants at risk
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of PF-04840082 18.0 mg/kg over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
Placebo
n=20 participants at risk
Healthy postmenopausal female participants with osteopenia and healthy male participants between the ages of 55-80 years received a single IV infusion of matching placebo over 60 minutes on Day 1 following an overnight fast of at least 6 hours.
|
|---|---|---|---|---|---|---|---|---|
|
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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Atrial fibrillation
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 tachycardia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Supraventricular tachycardia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Tinnitus
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Eye 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Abnormal faeces
|
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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Diarrhoea
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Dyspepsia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Gingival 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Oral disorder
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Stomatitis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Toothache
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Vomiting
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Infusion site 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Malaise
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Cystitis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Rhinitis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Upper respiratory tract infection
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
37.5%
3/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
4/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Ligament sprain
|
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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Thermal burn
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 pressure 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Arthralgia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.0%
3/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Back 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Muscle spasms
|
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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
25.0%
2/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Myalgia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Neck 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Pain in extremity
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 postural
|
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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
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.
|
37.5%
3/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Presyncope
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Tension headache
|
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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Insomnia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Haematuria
|
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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Cough
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Nasal 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Oropharyngeal 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Rhinorrhoea
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 contact
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Ecchymosis
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Papule
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Skin lesion
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
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.
|
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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/20
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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