NCT01326702 · OUTCOME
Response Rate
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
- 2 years
What was measured
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
Groups in this outcome
Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg
Bendamustine 70 mg/m2, ABT-888 50 mg
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
Bendamustine 90 mg/m2, ABT-888 50 mg
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
Bendamustine 90 mg/m2, ABT-888 100 mg BID
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
Bendamustine 90 mg/m2, ABT-888 150 mg BID
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
Bendamustine 90 mg/m2, ABT-888 200 mg BID
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
Bendamustine 90 mg/m2, ABT-888 300 mg BID
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
Bendamustine 90 mg/m2, ABT-888 400 mg BID
| Group | Source count |
|---|---|
| Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | 3 |
| Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | 3 |
| Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | 5 |
| Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | 2 |
| Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | 3 |
| Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | 14 |
| Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | 2 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
Progression of Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 0
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 0
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- title
- Progression of Disease
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 2
- units
- Participants
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
- groups
- description
- Bendamustine 70 mg/m2, ABT-888 50 mg
- id
- OG000
- title
- Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg
- description
- Bendamustine 90 mg/m2, ABT-888 50 mg
- id
- OG001
- title
- Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
- description
- Bendamustine 90 mg/m2, ABT-888 100 mg BID
- id
- OG002
- title
- Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
- description
- Bendamustine 90 mg/m2, ABT-888 150 mg BID
- id
- OG003
- title
- Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
- description
- Bendamustine 90 mg/m2, ABT-888 200 mg BID
- id
- OG004
- title
- Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
- description
- Bendamustine 90 mg/m2, ABT-888 300 mg BID
- id
- OG005
- title
- Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
- description
- Bendamustine 90 mg/m2, ABT-888 400 mg BID
- id
- OG006
- title
- Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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