TriangleNCT01793051 · OUTCOME
Symptom Reduction
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale*month
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline to 3 months (three cycles with assessments made at beginning of each)
What was measured
Minocycline tested for its ability to reduce the value of a patient's 3 month (± two days) area under the curve (AUC) for the mean of 5 symptoms: fatigue, pain, muscle weakness, numbness, and bone aches. The AUC is calculated using a trapezoidal approximation, derived by multiplying half of the base with the sum of the two heights. The two heights correspond to the two mean symptom scores computed at each of these assessments. The AUC is measured in units of mean MDASI score in days. The area for the subsequent trapezoid can be calculated in the same way. Given a baseline, weekly assessment schedule over a three month period and end of trial assessment, there will be a total of 14 trapezoids. The AUC is the sum of the area of the 14 trapezoids. Each of the trapezoid has a maximum value of 70 (0.5\*7 days\*(10+10)). Hence, the AUC will have a minimum score of 0 and a maximum score of 980. Higher AUC values indicate worse outcomes.
Groups in this outcome
Minocycline
Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
Placebo
Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
| Group | Source count |
|---|---|
| Minocycline | 33 |
| Placebo | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Minocycline | 26.02 | 17.72 | Not reported | Not reported | Not reported |
| Placebo | 26.65 | 21.19 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.72
- value
- 26.02
- group Id
- OG001
- spread
- 21.19
- value
- 26.65
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 36
- units
- Participants
- description
- Minocycline tested for its ability to reduce the value of a patient's 3 month (± two days) area under the curve (AUC) for the mean of 5 symptoms: fatigue, pain, muscle weakness, numbness, and bone aches. The AUC is calculated using a trapezoidal approximation, derived by multiplying half of the base with the sum of the two heights. The two heights correspond to the two mean symptom scores computed at each of these assessments. The AUC is measured in units of mean MDASI score in days. The area for the subsequent trapezoid can be calculated in the same way. Given a baseline, weekly assessment schedule over a three month period and end of trial assessment, there will be a total of 14 trapezoids. The AUC is the sum of the area of the 14 trapezoids. Each of the trapezoid has a maximum value of 70 (0.5\*7 days\*(10+10)). Hence, the AUC will have a minimum score of 0 and a maximum score of 980. Higher AUC values indicate worse outcomes.
- dispersion Type
- Standard Deviation
- groups
- description
- Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
- id
- OG000
- title
- Minocycline
- description
- Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline to 3 months (three cycles with assessments made at beginning of each)
- title
- Symptom Reduction
- type
- PRIMARY
- unit Of Measure
- units on a scale*month
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice