Systemic Sclerosis
Conditions
Keywords
pirfenidone, SSc-ILD, scleroderma, systemic sclerosis, interstitial lung disease
Brief summary
PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).
Interventions
DRUGPirfenidone
Pirfenidone will be administered orally at a dose of 267 mg one oral capsule TID (801 mg/day) for 1 or 2 weeks followed by two 267 mg oral capsules TID (1602 mg/day) for 1 or 2 weeks (titration period) and then three 267 mg oral capsules TID (2403 mg/day) for 12 weeks (maintenance period).
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis less than (\<) 7 years 2. Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan 3. Screening forced vital capacity (FVC) greater than equal to (\>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) \>=40% of the predicted value 4. At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate
Exclusion criteria
1. Clinically significant pulmonary hypertension 2. Known underlying liver disease 3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux 4. History of clinically significant asthma or chronic obstructive pulmonary disease 5. Active infection 6. Diagnosis of another connective tissue disorder 7. Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention 8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD) 9. Pregnancy or lactation 10. Creatinine clearance \<40 milliliters per minute (mL/min) 11. Prior use of pirfenidone 12. Unsuitable for enrollment or unlikely to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) | From baseline up to 28 days after the last dose of study drug (last dose = Week 16) | Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | From baseline up to 28 days after the last dose of study drug (last dose = Week 16) | An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Baseline, Weeks 4, 8, 12, and 16 | UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant's assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health. |
Countries
Canada, Italy, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pirfenidone: 2-Week Titration Group Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period). | 32 |
| Pirfenidone: 4-Week Titration Group Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period). | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Pirfenidone: 2-Week Titration Group | Pirfenidone: 4-Week Titration Group | Total |
|---|---|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 12.08 | 51.9 years STANDARD_DEVIATION 12.52 | 50.6 years STANDARD_DEVIATION 12.27 |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 31 / 32 | 30 / 31 |
| serious Total, serious adverse events | 3 / 32 | 0 / 31 |
Outcome results
Primary
Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: From baseline up to 28 days after the last dose of study drug (last dose = Week 16)
Population: Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pirfenidone: 2-Week Titration Group | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) | 96.9 percentage of participants |
| Pirfenidone: 4-Week Titration Group | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) | 96.8 percentage of participants |
Primary
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From baseline up to 28 days after the last dose of study drug (last dose = Week 16)
Population: Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pirfenidone: 2-Week Titration Group | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 9.4 percentage of participants |
| Pirfenidone: 4-Week Titration Group | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0.0 percentage of participants |
Secondary
University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores
UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant's assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Population: Safety population. n = number of participants analyzed at specified time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Week 12 (n=27, 30) | 0.1173 units on a scale | Standard Deviation 0.23488 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: CFB Week 8 (n=32, 31) | 0.1719 units on a scale | Standard Deviation 0.4728 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: CFB Week 12 (n=27, 30) | 0.0432 units on a scale | Standard Deviation 0.25154 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Week 12 (n=27, 30) | 0.0370 units on a scale | Standard Deviation 0.19245 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Week 16 (n=25, 28) | 0.0600 units on a scale | Standard Deviation 0.13502 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Week 12 (n=27, 30) | 0.5370 units on a scale | Standard Deviation 0.7061 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: CFB Week 16 (n=25, 28) | 0.0133 units on a scale | Standard Deviation 0.16607 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: CFB Week 8 (n=32, 31) | 0.1261 units on a scale | Standard Deviation 0.36875 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Baseline (n=32, 31) | 0.0937 units on a scale | Standard Deviation 0.26033 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: CFB Week 12 (n=27, 30) | 0.2130 units on a scale | Standard Deviation 0.59929 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Week 4 (n=32, 30) | 0.0937 units on a scale | Standard Deviation 0.21697 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Week 16 (n=25, 28) | 0.4800 units on a scale | Standard Deviation 0.61627 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: CFB Week 4 (n=32, 30) | 0.0000 units on a scale | Standard Deviation 0.17831 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Week 12 (n=27, 30) | 0.4306 units on a scale | Standard Deviation 0.41069 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Week 8 (n=32, 31) | 0.1181 units on a scale | Standard Deviation 0.33273 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: CFB Week 8 (n=32, 31) | 0.0243 units on a scale | Standard Deviation 0.11887 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: CFB Week 16 (n=25, 28) | 0.1200 units on a scale | Standard Deviation 0.45139 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Week 12 (n=27, 30) | 0.0493 units on a scale | Standard Deviation 0.13182 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: CFB Week 12 (n=27, 30) | 0.0123 units on a scale | Standard Deviation 0.12055 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Baseline (n=32, 31) | 0.3281 units on a scale | Standard Deviation 0.48542 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: CFB Week 4 (n=32, 31) | 0.0651 units on a scale | Standard Deviation 0.20058 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: CFB Week 16 (n=25, 28) | 0.0000 units on a scale | Standard Deviation 0.10627 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Week 4 (n=32, 31) | 0.3125 units on a scale | Standard Deviation 0.48775 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Baseline (n=32, 31) | 0.0313 units on a scale | Standard Deviation 0.17678 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Week 16 (n=25, 28) | 0.3950 units on a scale | Standard Deviation 0.3727 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Week 4 (n=32, 31) | 0.0313 units on a scale | Standard Deviation 0.17678 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: CFB Week 4 (n=32, 31) | 0.0000 units on a scale | Standard Deviation 0 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: CFB Week 4 (n=32, 31) | -0.0156 units on a scale | Standard Deviation 0.5748 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Week 8 (n=32, 31) | 0.0313 units on a scale | Standard Deviation 0.17678 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Baseline (n=32, 31) | 0.3398 units on a scale | Standard Deviation 0.34083 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: CFB Week 8 (n=32, 31) | 0.0000 units on a scale | Standard Deviation 0 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Week 8 (n=32, 31) | 0.2813 units on a scale | Standard Deviation 0.37968 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: CFB Week 16 (n=25, 28) | 0.0750 units on a scale | Standard Deviation 0.25259 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: CFB Week 12 (n=27, 30) | 0.0370 units on a scale | Standard Deviation 0.19245 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: CFB Week 8 (n=32, 31) | -0.0469 units on a scale | Standard Deviation 0.46419 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Week 16 (n=25, 28) | 0.0400 units on a scale | Standard Deviation 0.2 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Week 16 (n=25, 28) | 0.0266 units on a scale | Standard Deviation 0.0803 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: CFB Week 16 (n=25, 28) | 0.0400 units on a scale | Standard Deviation 0.2 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Week 12 (n=27, 30) | 0.2778 units on a scale | Standard Deviation 0.46685 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Baseline (n=32, 31) | 0.2422 units on a scale | Standard Deviation 0.40899 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: CFB Week 12 (n=27, 30) | -0.0556 units on a scale | Standard Deviation 0.56045 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Week 4 (n=32, 30) | 0.2656 units on a scale | Standard Deviation 0.34159 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Baseline (n=32, 31) | 0.3984 units on a scale | Standard Deviation 0.571 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: CFB Week 4 (n=32, 30) | 0.0234 units on a scale | Standard Deviation 0.42293 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Week 16 (n=25, 28) | 0.3400 units on a scale | Standard Deviation 0.51478 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Week 8 (n=32, 31) | 0.2578 units on a scale | Standard Deviation 0.39901 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Week 4 (n=32, 31) | 0.4727 units on a scale | Standard Deviation 0.4327 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: CFB Week 8 (n=32, 31) | 0.0156 units on a scale | Standard Deviation 0.2535 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Week 12 (n=27, 30) | 0.2407 units on a scale | Standard Deviation 0.38904 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: CFB Week 16 (n=25, 28) | 0.0400 units on a scale | Standard Deviation 0.57591 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: CFB Week 12 (n=27, 30) | 0.0370 units on a scale | Standard Deviation 0.37148 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Week 4 (n=32, 31) | 0.6406 units on a scale | Standard Deviation 0.65049 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Week 16 (n=25, 28) | 0.1800 units on a scale | Standard Deviation 0.29333 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: CFB Week 16 (n=25, 28) | 0.0200 units on a scale | Standard Deviation 0.37444 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Baseline (n=32, 31) | 0.1250 units on a scale | Standard Deviation 0.28078 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Baseline (n=32, 31) | 0.2194 units on a scale | Standard Deviation 0.24262 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: CFB Week 12 (n=27, 30) | 0.0880 units on a scale | Standard Deviation 0.35494 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Week 4 (n=32, 31) | 0.2845 units on a scale | Standard Deviation 0.28528 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Week 4 (n=32, 31) | 0.1563 units on a scale | Standard Deviation 0.26072 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: CFB Week 4 (n=32, 31) | 0.2422 units on a scale | Standard Deviation 0.41874 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Week 8 (n=32, 31) | 0.2759 units on a scale | Standard Deviation 0.26133 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: CFB Week 4 (n=32, 31) | 0.0313 units on a scale | Standard Deviation 0.25893 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: CFB Week 8 (n=32, 31) | 0.0564 units on a scale | Standard Deviation 0.15749 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: CFB Week 4 (n=32, 31) | 0.1328 units on a scale | Standard Deviation 0.36469 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Week 12 (n=27, 30) | 0.2416 units on a scale | Standard Deviation 0.25329 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Week 8 (n=32, 31) | 0.1886 units on a scale | Standard Deviation 0.31322 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: CFB Week 12 (n=27, 30) | 0.0564 units on a scale | Standard Deviation 0.1679 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Week 8 (n=32,31) | 0.5703 units on a scale | Standard Deviation 0.60985 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Week 16 (n=25, 28) | 0.2237 units on a scale | Standard Deviation 0.19767 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: CFB Week 8 (n=32, 31) | 0.0635 units on a scale | Standard Deviation 0.29233 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: CFB Week 16 (n=25, 28) | 0.0481 units on a scale | Standard Deviation 0.14444 |
| Pirfenidone: 2-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Week 8 (n=32, 31) | 0.4660 units on a scale | Standard Deviation 0.39881 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Week 12 (n=27, 30) | 0.0852 units on a scale | Standard Deviation 0.30979 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Week 12 (n=27, 30) | 0.2000 units on a scale | Standard Deviation 0.48423 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Week 8 (n=32, 31) | 0.0825 units on a scale | Standard Deviation 0.2968 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Week 4 (n=32, 31) | 0.1290 units on a scale | Standard Deviation 0.42755 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: CFB Week 8 (n=32, 31) | -0.0081 units on a scale | Standard Deviation 0.38989 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Week 16 (n=25, 28) | 0.1518 units on a scale | Standard Deviation 0.27504 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Baseline (n=32, 31) | 0.3347 units on a scale | Standard Deviation 0.29117 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Week 4 (n=32, 31) | 0.3548 units on a scale | Standard Deviation 0.36529 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Week 8 (n=32, 31) | 0.4389 units on a scale | Standard Deviation 0.46573 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: CFB Week 8 (n=32, 31) | 0.1043 units on a scale | Standard Deviation 0.41664 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Week 12 (n=27, 30) | 0.3417 units on a scale | Standard Deviation 0.33142 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: CFB Week 12 (n=27, 30) | 0.0042 units on a scale | Standard Deviation 0.26155 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: Week 16 (n=25, 28) | 0.3348 units on a scale | Standard Deviation 0.39682 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: CFB Week 16 (n=25, 28) | -0.0045 units on a scale | Standard Deviation 0.3182 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Baseline (n=32, 31) | 0.5968 units on a scale | Standard Deviation 0.58693 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Week 4 (n=32, 31) | 0.4919 units on a scale | Standard Deviation 0.65346 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: CFB Week 4 (n=32, 31) | -0.1048 units on a scale | Standard Deviation 0.50734 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Week 8 (n=32,31) | 0.4247 units on a scale | Standard Deviation 0.57188 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: CFB Week 8 (n=32, 31) | -0.1720 units on a scale | Standard Deviation 0.43245 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Week 12 (n=27, 30) | 0.4250 units on a scale | Standard Deviation 0.56152 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: CFB Week 12 (n=27, 30) | -0.1833 units on a scale | Standard Deviation 0.47766 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: Week 16 (n=25, 28) | 0.4286 units on a scale | Standard Deviation 0.48523 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Distention/Bloating: CFB Week 16 (n=25, 28) | -0.1518 units on a scale | Standard Deviation 0.45307 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Baseline (n=32, 31) | 0.2742 units on a scale | Standard Deviation 0.48026 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Week 4 (n=32, 31) | 0.2258 units on a scale | Standard Deviation 0.48026 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: CFB Week 4 (n=32, 31) | -0.0484 units on a scale | Standard Deviation 0.43503 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Week 8 (n=32, 31) | 0.3226 units on a scale | Standard Deviation 0.556 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: CFB Week 8 (n=32, 31) | 0.0484 units on a scale | Standard Deviation 0.58245 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: CFB Week 12 (n=27, 30) | -0.0667 units on a scale | Standard Deviation 0.58329 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: Week 16 (n=25, 28) | 0.2500 units on a scale | Standard Deviation 0.51819 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Diarrhea: CFB Week 16 (n=25, 28) | -0.0179 units on a scale | Standard Deviation 0.61587 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Baseline (n=32, 31) | 0.1893 units on a scale | Standard Deviation 0.43585 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Week 4 (n=32, 31) | 0.1775 units on a scale | Standard Deviation 0.27199 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: CFB Week 4 (n=32, 31) | -0.0118 units on a scale | Standard Deviation 0.28143 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Week 8 (n=32, 31) | 0.1936 units on a scale | Standard Deviation 0.33647 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: CFB Week 8 (n=32, 31) | 0.0044 units on a scale | Standard Deviation 0.37997 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Week 12 (n=27, 30) | 0.1944 units on a scale | Standard Deviation 0.30028 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: CFB Week 12 (n=27, 30) | -0.0011 units on a scale | Standard Deviation 0.3573 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: Week 16 (n=25, 28) | 0.1667 units on a scale | Standard Deviation 0.27596 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Social Functioning: CFB Week 16 (n=25, 28) | -0.0131 units on a scale | Standard Deviation 0.40515 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Baseline (n=32, 31) | 0.1326 units on a scale | Standard Deviation 0.4191 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Week 4 (n=32, 30) | 0.0778 units on a scale | Standard Deviation 0.32516 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: CFB Week 4 (n=32, 30) | -0.0593 units on a scale | Standard Deviation 0.14808 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: CFB Week 8 (n=32, 31) | -0.0502 units on a scale | Standard Deviation 0.19846 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Reflux: CFB Week 4 (n=32, 31) | 0.0202 units on a scale | Standard Deviation 0.26437 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: CFB Week 12 (n=27, 30) | -0.0482 units on a scale | Standard Deviation 0.14786 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: Week 16 (n=25, 28) | 0.0833 units on a scale | Standard Deviation 0.39959 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Emotional Wellbeing: CFB Week 16 (n=25, 28) | -0.0357 units on a scale | Standard Deviation 0.12851 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Baseline (n=32, 31) | 0.1290 units on a scale | Standard Deviation 0.42755 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: CFB Week 4 (n=32, 31) | 0.0000 units on a scale | Standard Deviation 0 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Week 8 (n=32, 31) | 0.1613 units on a scale | Standard Deviation 0.45437 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: CFB Week 8 (n=32, 31) | 0.0323 units on a scale | Standard Deviation 0.17961 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Week 12 (n=27, 30) | 0.1333 units on a scale | Standard Deviation 0.43417 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: CFB Week 12 (n=27, 30) | 0.0000 units on a scale | Standard Deviation 0 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: Week 16 (n=25, 28) | 0.1071 units on a scale | Standard Deviation 0.41627 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Fecal Soilage: CFB Week 16 (n=25, 28) | 0.0000 units on a scale | Standard Deviation 0 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Baseline (n=32, 31) | 0.1694 units on a scale | Standard Deviation 0.2613 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Week 4 (n=32, 30) | 0.1500 units on a scale | Standard Deviation 0.29066 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: CFB Week 4 (n=32, 30) | -0.0250 units on a scale | Standard Deviation 0.30336 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Week 8 (n=32, 31) | 0.1613 units on a scale | Standard Deviation 0.46345 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: Week 12 (n=27, 30) | 0.2111 units on a scale | Standard Deviation 0.36075 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: CFB Week 12 (n=27, 30) | 0.0528 units on a scale | Standard Deviation 0.49008 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Constipation: CFB Week 16 (n=25, 28) | -0.0179 units on a scale | Standard Deviation 0.42453 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Baseline (n=32, 31) | 0.2761 units on a scale | Standard Deviation 0.32679 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Week 4 (n=32, 31) | 0.2432 units on a scale | Standard Deviation 0.31264 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: CFB Week 4 (n=32, 31) | -0.0330 units on a scale | Standard Deviation 0.13591 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Week 8 (n=32, 31) | 0.2706 units on a scale | Standard Deviation 0.29132 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: CFB Week 8 (n=32, 31) | -0.0055 units on a scale | Standard Deviation 0.20053 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Week 12 (n=27, 30) | 0.2299 units on a scale | Standard Deviation 0.27136 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: CFB Week 12 (n=27, 30) | -0.0492 units on a scale | Standard Deviation 0.17709 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: Week 16 (n=25, 28) | 0.2284 units on a scale | Standard Deviation 0.26906 |
| Pirfenidone: 4-Week Titration Group | University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores | Total Score: CFB Week 16 (n=25, 28) | -0.0372 units on a scale | Standard Deviation 0.20737 |