NCT02663518 · OUTCOME
Part 2: Overall Response Rate (ORR)- Hallek 2008- Disease Indication
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
What was measured
ORR is presented in this outcome measure as number of responders. Responders were those who had complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment of tumors. Tumor types evaluated include chronic lymphocytic leukemia (CLL).
Analysis population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Groups in this outcome
Part 2: Chronic Lymphocytic Leukemia (CLL)
Participants with CLL who received study drug in part 2.
| Group | Source count |
|---|---|
| Part 2: Chronic Lymphocytic Leukemia (CLL) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Chronic Lymphocytic Leukemia (CLL) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- units
- Participants
- description
- ORR is presented in this outcome measure as number of responders. Responders were those who had complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment of tumors. Tumor types evaluated include chronic lymphocytic leukemia (CLL).
- groups
- description
- Participants with CLL who received study drug in part 2.
- id
- OG000
- title
- Part 2: Chronic Lymphocytic Leukemia (CLL)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
- title
- Part 2: Overall Response Rate (ORR)- Hallek 2008- Disease Indication
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle