TriangleNCT02207556 · OUTCOME
Hematologic Response
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
- 1 year
What was measured
This measure will record the number of subjects for each grade of response to therapy for subjects with Systematic Disease (hematologic) only. Hematologic response will be determined as follows. Complete response (CR) - Negative serum/urine immunofixation with normal Free Light Chain (FLC) ratio Very Good Partial Response (VGPR)- Difference between involved and uninvolved FLCs (dFLC) \< 40 mg/L Partial Response (PR)- dFLC decrease \> 50% No Response (NR)- less then PR.
Analysis population: Hematologic response is not relevant to subjects with localized disease. Subjects with localized disease were not included in this analysis. Five participants had expired by the 1 year time point
Groups in this outcome
Doxycycline (Systemic Disease)
Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.
| Group | Source count |
|---|---|
| Doxycycline (Systemic Disease) | 25 |
Reported measurements
Source class 1
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxycycline (Systemic Disease) | 6 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxycycline (Systemic Disease) | 3 | Not reported | Not reported | Not reported | Not reported |
Very Good Partial Response (VGPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxycycline (Systemic Disease) | 11 | Not reported | Not reported | Not reported | Not reported |
Expired at 1 year
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxycycline (Systemic Disease) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Complete Response (CR)
- measurements
- group Id
- OG000
- value
- 3
- title
- Partial Response (PR)
- measurements
- group Id
- OG000
- value
- 11
- title
- Very Good Partial Response (VGPR)
- measurements
- group Id
- OG000
- value
- 5
- title
- Expired at 1 year
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- This measure will record the number of subjects for each grade of response to therapy for subjects with Systematic Disease (hematologic) only. Hematologic response will be determined as follows. Complete response (CR) - Negative serum/urine immunofixation with normal Free Light Chain (FLC) ratio Very Good Partial Response (VGPR)- Difference between involved and uninvolved FLCs (dFLC) \< 40 mg/L Partial Response (PR)- dFLC decrease \> 50% No Response (NR)- less then PR.
- groups
- description
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met: * Patient has completed 1 year of doxycycline therapy * Patient develops any grade 3-4 toxicity related to doxycycline use.
- id
- OG000
- title
- Doxycycline (Systemic Disease)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Hematologic response is not relevant to subjects with localized disease. Subjects with localized disease were not included in this analysis. Five participants had expired by the 1 year time point
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Hematologic Response
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice