NCT00580788 · OUTCOME
Parathyroid Hormone (1-84)
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study · Source last updated 2016-02-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- pg/ml
- Interval / dispersion
- Standard Error
- Time frame
- Baseline and Daily
Groups in this outcome
Group 1
PTHrP(1-36) 2 picomoles/kg/hr for one week.
Group 2
PTHrP(1-36) 4 picomoles/kg/hr for one week.
Group 3
PTHrP(1-36) 5 picomoles/kg/hr for one week.
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Group 1 | 3 |
|---|
| Group 2 | 6 |
|---|
| Group 3 | 3 |
|---|
| Group 4 | 0 |
|---|
Reported measurements
baseline
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 42.97 | 2.86 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 30.70 | 5.56 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 48.27 | 15.93 | Not reported | Not reported | Not reported |
|---|
Day 2
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 23.47 | 1.48 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 7.82 | 1.50 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 3.60 | 0.50 | Not reported | Not reported | Not reported |
|---|
Day 3
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 21.43 | 3.65 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 5.23 | 1.75 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 3.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
Day 4
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 26.77 | 3.24 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 7.88 | 3.21 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 3.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
Day 5
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 22.37 | 5.10 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 7.54 | 1.80 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 3.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
Day 6
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 21.13 | 5.88 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 6.57 | 2.24 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 3.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
Day 7
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 19.40 | 4.03 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 5.67 | 1.20 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 3.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
Day 8
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 12.60 | 3.58 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 3.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 3.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
follow-up
Values in pg/ml · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 56.37 | 5.18 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 31.60 | 2.63 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 44.20 | 10.87 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Num Sides
- TWO_SIDED
- non Inferiority Comment
- The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.05
- p Value Comment
- the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8
- statistical Comment
- The level of statistical significance was set at .05 (two-tailed)
- statistical Method
- Mixed Models Analysis
- tested Non Inferiority
- true
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- non Inferiority Comment
- The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.05
- p Value Comment
- the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8
- statistical Comment
- The level of statistical significance was set at .05 (two-tailed)
- statistical Method
- Mixed Models Analysis
- tested Non Inferiority
- true
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.86
- value
- 42.97
- group Id
- OG001
- spread
- 5.56
- value
- 30.70
- group Id
- OG002
- spread
- 15.93
- value
- 48.27
- title
- baseline
- categories
- measurements
- group Id
- OG000
- spread
- 1.48
- value
- 23.47
- group Id
- OG001
- spread
- 1.50
- value
- 7.82
- group Id
- OG002
- spread
- 0.50
- value
- 3.60
- title
- Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 3.65
- value
- 21.43
- group Id
- OG001
- spread
- 1.75
- value
- 5.23
- group Id
- OG002
- spread
- 0.00
- value
- 3.00
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 3.24
- value
- 26.77
- group Id
- OG001
- spread
- 3.21
- value
- 7.88
- group Id
- OG002
- spread
- 0.00
- value
- 3.00
- title
- Day 4
- categories
- measurements
- group Id
- OG000
- spread
- 5.10
- value
- 22.37
- group Id
- OG001
- spread
- 1.80
- value
- 7.54
- group Id
- OG002
- spread
- 0.00
- value
- 3.00
- title
- Day 5
- categories
- measurements
- group Id
- OG000
- spread
- 5.88
- value
- 21.13
- group Id
- OG001
- spread
- 2.24
- value
- 6.57
- group Id
- OG002
- spread
- 0.00
- value
- 3.00
- title
- Day 6
- categories
- measurements
- group Id
- OG000
- spread
- 4.03
- value
- 19.40
- group Id
- OG001
- spread
- 1.20
- value
- 5.67
- group Id
- OG002
- spread
- 0.00
- value
- 3.00
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 3.58
- value
- 12.60
- group Id
- OG001
- spread
- 0.00
- value
- 3.00
- group Id
- OG002
- spread
- 0.00
- value
- 3.00
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 5.18
- value
- 56.37
- group Id
- OG001
- spread
- 2.63
- value
- 31.60
- group Id
- OG002
- spread
- 10.87
- value
- 44.20
- title
- follow-up
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- pg/ml
- dispersion Type
- Standard Error
- groups
- description
- PTHrP(1-36) 2 picomoles/kg/hr for one week.
- id
- OG000
- title
- Group 1
- description
- PTHrP(1-36) 4 picomoles/kg/hr for one week.
- id
- OG001
- title
- Group 2
- description
- PTHrP(1-36) 5 picomoles/kg/hr for one week.
- id
- OG002
- title
- Group 3
- description
- PTHrP(1-36) 6 picomoles/kg/hr for one week.
- id
- OG003
- title
- Group 4
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline and Daily
- title
- Parathyroid Hormone (1-84)
- type
- SECONDARY
- unit Of Measure
- pg/ml
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