NCT03849651 · OUTCOME
The Cumulative Incidence of Any Severity Chronic Graft-Versus-Host Disease (GVHD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- One year after receiving transplant
What was measured
Kalbfleisch and Prentice estimate of the percentage of experiencing any severity chronic GVHD one year after the date of transplant. (Events=chronic GVHD, competing events=death) Groups with insufficient events for confidence interval estimation have confidence intervals written as "NA to NA."
Analysis population: Patients who met eligibility criteria and received transplant.
Groups in this outcome
All Transplant Participants
Patients who met eligibility criteria and received transplant.
Dose 1
Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg
Dose 2
Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg
Dose 3
Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg
Phase 2
Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
| Group | Source count |
|---|---|
| All Transplant Participants | 69 |
| Dose 1 | 9 |
| Dose 2 | 10 |
| Dose 3 | 10 |
| Phase 2 | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Transplant Participants | 4.3 | Not reported | 1.1 | 11.1 | Not reported |
| Dose 1 | 0 | Not reported | NA | NA | No patients experienced outcome, so confidence interval is not applicable"? |
| Dose 2 | 10.0 | Not reported | 0.4 | 37.6 | Not reported |
| Dose 3 | 10.0 | Not reported | 0.5 | 37.4 | Not reported |
| Phase 2 | 2.5 | Not reported | 0.2 | 11.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 11.1
- value
- 4.3
- comment
- No patients experienced outcome, so confidence interval is not applicable"?
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG002
- lower Limit
- 0.4
- upper Limit
- 37.6
- value
- 10.0
- group Id
- OG003
- lower Limit
- 0.5
- upper Limit
- 37.4
- value
- 10.0
- group Id
- OG004
- lower Limit
- 0.2
- upper Limit
- 11.4
- value
- 2.5
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 40
- units
- Participants
- description
- Kalbfleisch and Prentice estimate of the percentage of experiencing any severity chronic GVHD one year after the date of transplant. (Events=chronic GVHD, competing events=death) Groups with insufficient events for confidence interval estimation have confidence intervals written as "NA to NA."
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients who met eligibility criteria and received transplant.
- id
- OG000
- title
- All Transplant Participants
- description
- Patients who met eligibility criteria, received transplant, and received 1x10\^5 cells/kg
- id
- OG001
- title
- Dose 1
- description
- Patients who met eligibility criteria, received transplant, and received 1x10\^6 cells/kg
- id
- OG002
- title
- Dose 2
- description
- Patients who met eligibility criteria, received transplant, and received 1x10\^7 cells/kg
- id
- OG003
- title
- Dose 3
- description
- Patients who met eligibility criteria, received transplant, and were assigned the MED dose of 1x10\^7 cells/kg
- id
- OG004
- title
- Phase 2
- param Type
- NUMBER
- population Description
- Patients who met eligibility criteria and received transplant.
- reporting Status
- POSTED
- time Frame
- One year after receiving transplant
- title
- The Cumulative Incidence of Any Severity Chronic Graft-Versus-Host Disease (GVHD)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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