TriangleNCT03945019 · OUTCOME
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
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 54
What was measured
Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value. AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Analysis population: All-randomized population
Groups in this outcome
CT-P13 SC 120 mg
CT-P13 SC 120 mg
Placebo
Placebo
| Group | Source count |
|---|---|
| CT-P13 SC 120 mg | 231 |
| Placebo | 112 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CT-P13 SC 120 mg | 131 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 35 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 131
- group Id
- OG001
- value
- 35
- denoms
- counts
- group Id
- OG000
- value
- 231
- group Id
- OG001
- value
- 112
- units
- Participants
- description
- Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value. AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
- groups
- description
- CT-P13 SC 120 mg
- id
- OG000
- title
- CT-P13 SC 120 mg
- description
- Placebo
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All-randomized population
- reporting Status
- POSTED
- time Frame
- Week 54
- title
- Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice