TriangleNCT01311687 · OUTCOME
Time to the First Hemoglobin Improvement
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- Full Range
- Time frame
- From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
What was measured
Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are: 1) Normal; 2) CTCAE Grade 1: \< lower limit of normal (LLN) to 10.0 g/dL; 3) CTCAE Grade 2: \< 10.0 to \<8.0 g/dL. Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study.
Analysis population: Intent-to-treat population with improvement in hemoglobin during the study
Groups in this outcome
Pomalidomide Plus Low-Dose Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
High-Dose Dexamethasone
Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
| Group | Source count |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 144 |
| High-Dose Dexamethasone | 50 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 3.4 | Not reported | 1.1 | 49.3 | Not reported |
| High-Dose Dexamethasone | 1.3 | Not reported | 0.9 | 24.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 49.3
- value
- 3.4
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 24.3
- value
- 1.3
- denoms
- counts
- group Id
- OG000
- value
- 144
- group Id
- OG001
- value
- 50
- units
- Participants
- description
- Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are: 1) Normal; 2) CTCAE Grade 1: \< lower limit of normal (LLN) to 10.0 g/dL; 3) CTCAE Grade 2: \< 10.0 to \<8.0 g/dL. Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study.
- dispersion Type
- Full Range
- groups
- description
- Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
- id
- OG000
- title
- Pomalidomide Plus Low-Dose Dexamethasone
- description
- Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
- id
- OG001
- title
- High-Dose Dexamethasone
- param Type
- MEDIAN
- population Description
- Intent-to-treat population with improvement in hemoglobin during the study
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
- title
- Time to the First Hemoglobin Improvement
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice