TriangleNCT04173494 · OUTCOME
Duration of MFSAF TSS Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Up to a maximum of 151 weeks
What was measured
Duration of MFSAF TSS response is defined as the number of days from the start of the initial 28-day period in which a participant had a \>= 50% reduction from Baseline TSS to the first day of the 7-day assessment that determines the mean TSS for the 28-day period during which the participants TSS equals or exceeds their Baseline value.
Analysis population: ITT Analysis Set. Only those participants with data available at specified time point were analyzed.
Groups in this outcome
MMB 200 mg QD + Placebo
Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.
DAN 300 mg BID + Placebo
Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.
| Group | Source count |
|---|---|
| MMB 200 mg QD + Placebo | 32 |
| DAN 300 mg BID + Placebo | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MMB 200 mg QD + Placebo | 286.00 | Not reported | 286.00 | 286.00 | Not reported |
| DAN 300 mg BID + Placebo | NA | Not reported | NA | NA | \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 286.00
- upper Limit
- 286.00
- value
- 286.00
- comment
- \<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Duration of MFSAF TSS response is defined as the number of days from the start of the initial 28-day period in which a participant had a \>= 50% reduction from Baseline TSS to the first day of the 7-day assessment that determines the mean TSS for the 28-day period during which the participants TSS equals or exceeds their Baseline value.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.
- id
- OG000
- title
- MMB 200 mg QD + Placebo
- description
- Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.
- id
- OG001
- title
- DAN 300 mg BID + Placebo
- param Type
- MEDIAN
- population Description
- ITT Analysis Set. Only those participants with data available at specified time point were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to a maximum of 151 weeks
- title
- Duration of MFSAF TSS Response
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice