Trial · NCT02449044
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Adverse Events (AEs) | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| PRIMARY | Participants With Laboratory Values Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| PRIMARY | Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| PRIMARY | Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs) | Baseline to Post-Week 214 follow-up visit | The intent-to-treat (ITT) dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| PRIMARY | Participants With Body Weight Abnormalities Reported as TEAEs | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Serum Sodium Measurements | Baseline of parent trial to Week 214 | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | mEq/L | MEAN |
| SECONDARY | Change From Baseline in Percentage of Participants With Severe Hyponatremia | Baseline to Week 214 | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Percentage of Participants With Mild Hyponatremia | Baseline to Week 214 | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Percentage of Participants With Normal Sodium Levels | Baseline to Week 214 | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring Prescription of Fluid Restriction | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Requiring Prescription of Hypertonic Saline | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring prescription of hypertonic saline was not analyzed due to a low number of participants who received the treatment. | participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring Prescription of Other Medicines | Baseline to Post-Week 214 follow-up visit | The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring other medicines such as demeclocycline or urea was not analyzed. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Body Weight by Visit for Those Participants Who Had Clinical Evidence of Hypervolemia at Baseline | Baseline to Week 214 | The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. The observed cases (OC) dataset consisted of only data points obtained from participants who were evaluated at the visit, without missing study drug consecutively for 14 days. | kg | MEAN |
| SECONDARY | Mean Change From Baseline in SF-12 (Health Survey) Physical Component Summary (PCS) | Baseline to Week 214 | The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in SF-12 (Health Survey) Mental Component Summary (MCS) | Baseline to Week 214 | The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Hyponatremia Disease-specific Survey | Baseline to Week 214 | The Hyponatremia Disease-specific Survey PCS and MCS scores evaluated during the trial were variable with only nominal changes from baseline observed. The data were collected under 2 different datasets, so the number of participants in each dataset was reduced that limited analysis of this endpoint. |
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.
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