Trial · NCT02656017
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Gastrointestinal Symptoms Rating Scale (GSRS) to 24 Months | Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months | GSRS is a widely used, validated 15-item questionnaire used to assess GI symptom burden (minimum, maximum: 1, 7, where higher mean score is worse outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. |
| Primary | Drug Tolerability | Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months | Tolerability was based on the first visit a participant responded no to the following question "Can you tolerate this dose of study drug the rest of your life?", which was asked at baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months. |
| Primary | Rate of Serious Adverse Events (SAE) | 26 months | Serious adverse events (SAE) occurring from the time a participant signs the informed consent (at the screening visit) until the end of the study, meeting 1 or more of the criteria of: 1) Resulting in death, 2) Non-elective hospitalization, 3) Life threatening (if patient continued on study drug would result in death), 4) Harming or disabling persistently or permanently , 5) Exceeding the nature, severity or frequency of risk described in the protocol or 6) Resulting in congenital anomaly. |
| Secondary | Quality of Life Physical Component | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months | Short Form-36 Quality of Life Physical Component Summary (SF-36 PCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. |
| Secondary | Quality of Life Mental Component | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months | Short Form-36 Quality of Life Mental Component Summary (SF-36 MCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. |
| Secondary | Back Pain Frequency Over the Past 3 Months Since Last Visit | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months | Odds ratio (OR) per month of back pain Often, Usually, or Always (vs. Never, Rarely, Sometimes) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. |
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | Baseline, 2 weeks, and 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months | Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model. |
| Secondary | Total Kidney Volume From Magnetic Resonance Imaging | Baseline, 6 months, 12 months, 18 months, 24 months | Annual percent change of height adjusted and natural log transformed total kidney volume \[ln(htTKV)\] was estimated with a linear mixed model. |
| Secondary | Total Kidney Cyst Volume From Magnetic Resonance Imaging | Baseline, 6 months, 12 months, 18 months, 24 months | Annual percent change of height adjusted and natural log transformed total kidney cyst volume \[ln(htTKCV)\] was estimated with a linear mixed model. |
| Secondary | Liver Volume From Magnetic Resonance Imaging | Baseline, 6 months, 12 months, 18 months, 24 months | Annual percent change of height adjusted and natural log transformed liver volume \[ln(htLV)\] was estimated with a linear mixed model. |
| Secondary | Liver Cyst Volume From Magnetic Resonance Imaging | Baseline, 6 months, 12 months, 18 months, 24 months | Annual percent change of height adjusted and natural log transformed liver cyst volume \[ln(htLCV)\] was estimated with a linear mixed model. |
| Secondary | Frequency Abdominal Fullness Interfered With Ability to Perform Usual Physical Activity Over the Past 3 Months Since Last Visit. | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months | Odds ratio (OR) per month of abdominal fullness interfered Often, Usually, or Always (vs. Never, Rarely, Sometimes) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. |
| Secondary | Interference of Pain With Sleep Over the Past 3 Months Since Last Visit | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months | Odds ratio (OR) per month of pain interfered with sleep Quite a bit or Extremely (vs. Not at all, A little bit, Moderately) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. |
| Secondary | Interference of Pain With Strenuous Physical Activity Over the Past 3 Months Since Last Visit | Baseline, 1 month, 3 months and every 3 months thereafter to 24 months | Odds ratio (OR) per month of pain interfered with strenuous physical activity Quite a bit or Extremely (vs. Not at all, A little bit, Moderately) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02656017/registered