Trial · NCT03044353
Outcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Grams | MEAN |
| PRIMARY | Number of Participants With Any On-treatment Adverse Events (AEs) | Up to 56 days after the last dosing session (up to 265 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Serious Adverse Events (SAEs) | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Hematology Values | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinical Chemistry Values | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Urinalysis Results | Up to the end of study (Up to 369 days) | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Up to the end of study (Up to 369 days) | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities During Cardiac Monitoring | Up to the end of study (Up to 369 days) | Safety Population. Only those participants with data available at the specified time point was analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons | Up to the end of study (Up to 369 days) | Safety Population. Only those participants with data available at the specified time point was analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Skin Rashes | Up to 56 days after the last dosing session (up to 265 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Skin Rashes Classified Using CTCAE | Up to 56 days after the last dosing session (up to 265 days) | Safety Population. Only those participants with data available at the specified time point was analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies | Up to the end of study (Up to 369 days) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Histopathological Examination of Blood Biomarkers | Up to the end of study (Up to 369 days) | Safety Population. Data was not collected due to project termination. | ||
| SECONDARY | Number of Participants With Abnormalities in Immunohistochemical Examination of Blood Biomarkers | Up to the end of study (Up to 369 days) | Safety Population. Data was not collected due to project termination. | ||
| SECONDARY | Change From Baseline in Plasma Cytokines Over Time | Baseline (Day -1) and Session 1: Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5; Session 2 to 6: Day -2, Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5 | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Nanograms per liter (ng/L) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03044353/outcomes