NCT01582061 · OUTCOME
Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)
An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. · Source last updated 2018-06-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, week 12, 24 and 48
What was measured
The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.
Analysis population: LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method
Groups in this outcome
Pasireotide 600 μg
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.
Pasireotide 900 μg
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
All Patients
Patients received pasireotide 600 μg or 900 μg BID
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 |
|---|
| Pasireotide 600 μg | 49 |
|---|
| Pasireotide 900 μg | 55 |
|---|
| All Patients | 104 |
|---|
Reported measurements
Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 27 |
|---|
| Pasireotide 900 μg | 39 |
|---|
| All Patients | 66 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | 77.8 | Not reported | 57.74 | 91.38 | Not reported |
|---|
| Pasireotide 900 μg | 38.5 | Not reported | 23.36 | 55.38 | Not reported |
|---|
| All Patients | 54.5 | Not reported | 41.81 | 66.86 | Not reported |
|---|
Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 22 |
|---|
| Pasireotide 900 μg | 24 |
|---|
| All Patients | 46 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | 68.2 | Not reported | 45.13 | 86.14 | Not reported |
|---|
| Pasireotide 900 μg | 29.2 | Not reported | 12.62 | 51.09 | Not reported |
|---|
| All Patients | 47.8 | Not reported | 32.89 | 63.05 | Not reported |
|---|
Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 10 |
|---|
| Pasireotide 900 μg | 11 |
|---|
| All Patients | 21 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | 70.0 | Not reported | 34.75 | 93.33 | Not reported |
|---|
| Pasireotide 900 μg | 18.2 | Not reported | 2.28 | 51.78 | Not reported |
|---|
| All Patients | 42.9 | Not reported | 21.82 | 65.98 | Not reported |
|---|
Week 24 (LOCF)
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 37 |
|---|
| Pasireotide 900 μg | 49 |
|---|
| All Patients | 86 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | 54.1 | Not reported | 36.92 | 70.51 | Not reported |
|---|
| Pasireotide 900 μg | 28.6 | Not reported | 16.59 | 43.26 | Not reported |
|---|
| All Patients | 39.5 | Not reported | 29.15 | 50.66 | Not reported |
|---|
Week 48 (LOCF)
Analysis denominator · Participants
| Group | Source count |
|---|
| Pasireotide 600 μg | 37 |
|---|
| Pasireotide 900 μg | 49 |
|---|
| All Patients | 86 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pasireotide 600 μg | 51.4 | Not reported | 34.40 | 68.08 | Not reported |
|---|
| Pasireotide 900 μg | 22.4 | Not reported | 11.78 | 36.62 | Not reported |
|---|
| All Patients | 34.9 | Not reported | 24.92 | 45.92 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 57.74
- upper Limit
- 91.38
- value
- 77.8
- group Id
- OG001
- lower Limit
- 23.36
- upper Limit
- 55.38
- value
- 38.5
- group Id
- OG002
- lower Limit
- 41.81
- upper Limit
- 66.86
- value
- 54.5
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 39
- group Id
- OG002
- value
- 66
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.13
- upper Limit
- 86.14
- value
- 68.2
- group Id
- OG001
- lower Limit
- 12.62
- upper Limit
- 51.09
- value
- 29.2
- group Id
- OG002
- lower Limit
- 32.89
- upper Limit
- 63.05
- value
- 47.8
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 46
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.75
- upper Limit
- 93.33
- value
- 70.0
- group Id
- OG001
- lower Limit
- 2.28
- upper Limit
- 51.78
- value
- 18.2
- group Id
- OG002
- lower Limit
- 21.82
- upper Limit
- 65.98
- value
- 42.9
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 21
- units
- Participants
- title
- Week 48
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.92
- upper Limit
- 70.51
- value
- 54.1
- group Id
- OG001
- lower Limit
- 16.59
- upper Limit
- 43.26
- value
- 28.6
- group Id
- OG002
- lower Limit
- 29.15
- upper Limit
- 50.66
- value
- 39.5
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 86
- units
- Participants
- title
- Week 24 (LOCF)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.40
- upper Limit
- 68.08
- value
- 51.4
- group Id
- OG001
- lower Limit
- 11.78
- upper Limit
- 36.62
- value
- 22.4
- group Id
- OG002
- lower Limit
- 24.92
- upper Limit
- 45.92
- value
- 34.9
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 86
- units
- Participants
- title
- Week 48 (LOCF)
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 104
- units
- Participants
- description
- The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.
- id
- OG000
- title
- Pasireotide 600 μg
- description
- Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
- id
- OG001
- title
- Pasireotide 900 μg
- description
- Patients received pasireotide 600 μg or 900 μg BID
- id
- OG002
- title
- All Patients
- param Type
- NUMBER
- population Description
- LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method
- reporting Status
- POSTED
- time Frame
- Baseline, week 12, 24 and 48
- title
- Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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