TriangleNCT01064310 · OUTCOME
Time to Dose Modification
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- End of second treatment period (maximum of 22 weeks)
What was measured
For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.
Analysis population: Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.
Groups in this outcome
Sunitinib
Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
Pazopanib
Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
| Group | Source count |
|---|---|
| Sunitinib | 30 |
| Pazopanib | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 3.7 | Not reported | 2.7 | 5.9 | Not reported |
| Pazopanib | 4.0 | Not reported | 2.1 | 6.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.7
- upper Limit
- 5.9
- value
- 3.7
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 6.0
- value
- 4.0
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
- id
- OG000
- title
- Sunitinib
- description
- Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
- id
- OG001
- title
- Pazopanib
- param Type
- MEDIAN
- population Description
- Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.
- reporting Status
- POSTED
- time Frame
- End of second treatment period (maximum of 22 weeks)
- title
- Time to Dose Modification
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice