NCT00896454 · OUTCOME
Change From Baseline in Corrected Serum Calcium
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium · Source last updated 2018-10-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- mmol/L
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
Analysis population: Efficacy Analysis Subset included all participants who received at least 1 dose of denosumab. n = Number of participants who had non-missing data at Baseline and the time point of interest.
Groups in this outcome
Denosumab
Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
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 |
|---|
| Denosumab | 33 |
|---|
Reported measurements
Change from Baseline to Day 2 (n = 32)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.13 | Not reported | -0.31 | 0.09 | Not reported |
|---|
Change from Baseline to Day 4 (n = 32)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.25 | Not reported | -0.44 | -0.14 | Not reported |
|---|
Change form Baseline to Day 8 (n = 27)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.43 | Not reported | -0.73 | -0.20 | Not reported |
|---|
Change from Baseline to Day 10 (n = 28)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.54 | Not reported | -0.77 | -0.25 | Not reported |
|---|
Change from Baseline to Day 15 (n = 24)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.51 | Not reported | -0.89 | -0.15 | Not reported |
|---|
Change from Baseline to Day 19 (n = 22)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.64 | Not reported | -0.80 | -0.30 | Not reported |
|---|
Change from Baseline to Day 23 (n = 21)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.60 | Not reported | -0.85 | -0.40 | Not reported |
|---|
Change from Baseline to Day 29 (n = 22)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.53 | Not reported | -0.75 | -0.30 | Not reported |
|---|
Change from Baseline to Day 36 (n = 20)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.61 | Not reported | -0.84 | -0.15 | Not reported |
|---|
Change from Baseline to Day 43 (n = 19)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.75 | Not reported | -0.98 | -0.10 | Not reported |
|---|
Change from Baseline to Day 50 (n = 15)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.83 | Not reported | -1.03 | -0.20 | Not reported |
|---|
Change from Baseline to Day 57 (n = 17)
Values in mmol/L · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | -0.73 | Not reported | -1.03 | -0.25 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.31
- upper Limit
- 0.09
- value
- -0.13
- title
- Change from Baseline to Day 2 (n = 32)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.44
- upper Limit
- -0.14
- value
- -0.25
- title
- Change from Baseline to Day 4 (n = 32)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.73
- upper Limit
- -0.20
- value
- -0.43
- title
- Change form Baseline to Day 8 (n = 27)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.77
- upper Limit
- -0.25
- value
- -0.54
- title
- Change from Baseline to Day 10 (n = 28)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.89
- upper Limit
- -0.15
- value
- -0.51
- title
- Change from Baseline to Day 15 (n = 24)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.80
- upper Limit
- -0.30
- value
- -0.64
- title
- Change from Baseline to Day 19 (n = 22)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.85
- upper Limit
- -0.40
- value
- -0.60
- title
- Change from Baseline to Day 23 (n = 21)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.75
- upper Limit
- -0.30
- value
- -0.53
- title
- Change from Baseline to Day 29 (n = 22)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.84
- upper Limit
- -0.15
- value
- -0.61
- title
- Change from Baseline to Day 36 (n = 20)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.98
- upper Limit
- -0.10
- value
- -0.75
- title
- Change from Baseline to Day 43 (n = 19)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.03
- upper Limit
- -0.20
- value
- -0.83
- title
- Change from Baseline to Day 50 (n = 15)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.03
- upper Limit
- -0.25
- value
- -0.73
- title
- Change from Baseline to Day 57 (n = 17)
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
- id
- OG000
- title
- Denosumab
- param Type
- MEDIAN
- population Description
- Efficacy Analysis Subset included all participants who received at least 1 dose of denosumab. n = Number of participants who had non-missing data at Baseline and the time point of interest.
- reporting Status
- POSTED
- time Frame
- Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
- title
- Change From Baseline in Corrected Serum Calcium
- type
- SECONDARY
- unit Of Measure
- mmol/L
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