TriangleNCT00651937 · OUTCOME
Mean Symptom Severity Burden as Measured by MDASI Scores
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- 28 day course of ASCT
What was measured
MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10)
Analysis population: Intention to treat analysis, all treated participants. One participant in High Dose group did not complete adequate number of MDSAIs for analysis.
Groups in this outcome
Standard Dose Stem Cell Group
Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive either a standard (4-6×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
High Dose Stem Cell Group
Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive high dose (10-15×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
| Group | Source count |
|---|---|
| Standard Dose Stem Cell Group | 35 |
| High Dose Stem Cell Group | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Dose Stem Cell Group | 228.4 | 191.0 | Not reported | Not reported | Not reported |
| High Dose Stem Cell Group | 223.0 | 94.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 191.0
- value
- 228.4
- group Id
- OG001
- spread
- 94.0
- value
- 223.0
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10)
- dispersion Type
- Standard Deviation
- groups
- description
- Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive either a standard (4-6×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
- id
- OG000
- title
- Standard Dose Stem Cell Group
- description
- Patients undergoing ASCT for MM who were ≥60 years old or had AL amyloidosis were randomized to receive high dose (10-15×106 cells/kg) of CD34+ cells after melphalan 200 mg/m2.
- id
- OG001
- title
- High Dose Stem Cell Group
- param Type
- MEAN
- population Description
- Intention to treat analysis, all treated participants. One participant in High Dose group did not complete adequate number of MDSAIs for analysis.
- reporting Status
- POSTED
- time Frame
- 28 day course of ASCT
- title
- Mean Symptom Severity Burden as Measured by MDASI Scores
- type
- PRIMARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice