TriangleNCT01321554 · OUTCOME
Overall Response Rate (ORR)
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
- Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
What was measured
ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Analysis population: The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.
Groups in this outcome
Randomization Phase: Lenvatinib 24 mg
Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
Randomization Phase: Placebo
Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
| Group | Source count |
|---|---|
| Randomization Phase: Lenvatinib 24 mg | 261 |
| Randomization Phase: Placebo | 131 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase: Lenvatinib 24 mg | 64.8 | Not reported | 59.0 | 70.5 | Not reported |
| Randomization Phase: Placebo | 1.5 | Not reported | 0.0 | 3.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 59.0
- upper Limit
- 70.5
- value
- 64.8
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 3.6
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 261
- group Id
- OG001
- value
- 131
- units
- Participants
- description
- ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Randomization Phase: Lenvatinib 24 mg
- description
- Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- Randomization Phase: Placebo
- param Type
- NUMBER
- population Description
- The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice