TriangleNCT00408681 · OUTCOME
Mucosal Anatomic Recovery
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
- 4 weeks after starting treatment with the study product
What was measured
Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
Analysis population: Only 2 patients had endoscopic evaluation during this time window.
Groups in this outcome
Treated Patients
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Treated Patients | 2 |
Reported measurements
Source class 1
Limited improvement
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treated Patients | 1 | Not reported | Not reported | Not reported | Not reported |
Partial improvement
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treated Patients | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Limited improvement
- measurements
- group Id
- OG000
- value
- 1
- title
- Partial improvement
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
- groups
- description
- Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Treated Patients
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Only 2 patients had endoscopic evaluation during this time window.
- reporting Status
- POSTED
- time Frame
- 4 weeks after starting treatment with the study product
- title
- Mucosal Anatomic Recovery
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice