Trial · NCT03000673
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017) | All treated participants | Participants | NUMBER |
| PRIMARY | The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.) | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate | Days -3 to -1, Days 1, 5, 8, and 12. | All treated participants | Beats/min | MEAN |
| PRIMARY | The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate | Days -3 to -1, Days 1, 5, 8, and 12. | All treated participants | msec | MEAN |
| PRIMARY | The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate | Days -3 to -1, Days 1, 5, 8, and 12. | All treated participants | msec | MEAN |
| PRIMARY | The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate | Days -3 to -1, Days 1, 5, 8, and 12. | All treated participants | msec | MEAN |
| PRIMARY | The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate | Days -3 to -1, Days 1, 5, 8, and 12 | All treated participants | msec | MEAN |
| PRIMARY | The Change From Baseline in Vital Signs: Diastolic Blood Pressure | Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15 | All treated participants | mmHg | MEAN |
| PRIMARY | The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg) | Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15 | All treated participants | mmHg | MEAN |
| SECONDARY | Pharmacokinetic Parameters of BMS-986177: Cmax | Either Day 1, 5, 8, or 12 depending on the randomization sequence | All treated and evaluable participants | ng/mL | MEAN |
| PRIMARY | The Change From Baseline in Vital Signs: Heart Rate (Beats/Min) | Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15 | All treated participants | beats/min | MEAN |
| SECONDARY | Pharmacokinetic Parameters of BMS-986177: Tmax | Either Day 1, 5, 8, or 12 depending on the randomization sequence | All treated and evaluable participants | h | MEAN |
| SECONDARY | Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24) | Either Day 1, 5, 8, or 12 depending on the randomization sequence | All treated and evaluable participants | ng.h/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameters of BMS-986177: fu | Either Day 1, 5, 8, or 12 depending on the randomization sequence | All treated and evaluable participants | Percentage | MEAN |
| SECONDARY | Pharmacokinetic Parameters of BMS-986177: Cmaxfu | Either Day 1, 5, 8, or 12 depending on the randomization sequence | All treated and evaluable participants | ng/mL | MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03000673/outcomes