TriangleNCT01969838 · OUTCOME
Total Symptom Score (TSS) Response Rate at Week 24
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
- Week 24
What was measured
Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available. The modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of the Total Symptom Score (TSS), in this study was based on 7 of these items, (range of 0-70,), excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 being the worse
Analysis population: TSS rate analysis at Week 24 only included participants with TSS \> 0 at baseline or with TSS = 0 at baseline but with TSS \> 0 or missing at Week 24.
Groups in this outcome
Momelotinib (MMB)
Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
Ruxolitinib (RUX)
Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
| Group | Source count |
|---|---|
| Momelotinib (MMB) | 211 |
| Ruxolitinib (RUX) | 211 |
Reported measurements
Source class 1
Responder
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Momelotinib (MMB) | 60 | Not reported | Not reported | Not reported | Not reported |
| Ruxolitinib (RUX) | 89 | Not reported | Not reported | Not reported | Not reported |
Nonresponder
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Momelotinib (MMB) | 151 | Not reported | Not reported | Not reported | Not reported |
| Ruxolitinib (RUX) | 122 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.08
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.08
- group Ids
- OG000
- OG001
- non Inferiority Comment
- To evaluate the noninferiority of MMB over RUX, a conventional 2-sided CI was calculated for the difference in TSS response rate at Week 24: delta = prob(MMB) - 0.67\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared to be noninferior to RUX in TSS response rate at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is called the noninferiority proportion difference.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- 0.98
- param Type
- Proportion Difference - Stratified CMH
- param Value
- 0.00
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -0.08
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.08
- group Ids
- OG000
- OG001
- non Inferiority Comment
- To evaluate the noninferiority of MMB over RUX, a conventional 2-sided CI was calculated for the difference in TSS response rate at Week 24: delta = prob(MMB) - 0.67\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared to be noninferior to RUX in TSS response rate at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is called the noninferiority proportion difference.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- 0.98
- param Type
- Proportion Difference - Stratified CMH
- param Value
- 0.00
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 89
- title
- Responder
- measurements
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 122
- title
- Nonresponder
- denoms
- counts
- group Id
- OG000
- value
- 211
- group Id
- OG001
- value
- 211
- units
- Participants
- description
- Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available. The modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of the Total Symptom Score (TSS), in this study was based on 7 of these items, (range of 0-70,), excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 being the worse
- groups
- description
- Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
- id
- OG000
- title
- Momelotinib (MMB)
- description
- Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
- id
- OG001
- title
- Ruxolitinib (RUX)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- TSS rate analysis at Week 24 only included participants with TSS \> 0 at baseline or with TSS = 0 at baseline but with TSS \> 0 or missing at Week 24.
- reporting Status
- POSTED
- time Frame
- Week 24
- title
- Total Symptom Score (TSS) Response Rate at Week 24
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice