Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 22

Download this page as JSON

List	Outcome	Time frame	Description
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)	Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death
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.	HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW \< 0.85\PRE-RX; HEMATOCRIT HCT % LOW \< 0.85\PRE-RX; PLATELET COUNT PLAT X10\9 C/L LOW \< 0.85\LLN IF PRE-RX IS MISSING; \< 0.85\LLN IF PRE-RX \>= LLN; \< 0.85\PRE-RX IF PRE-RX \< LLN; HIGH \> 1.5\ULN; HEMATOLOGY II; LEUKOCYTES WBC X10\3 C/UL LOW \< 0.9\LLN IF PRE-RX IS MISSING; \< 0.9\LLN IF LLN \<= PRE-RX \<= ULN; \< 0.85\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.2\ULN IF PRE-RX IS MISSING; \> 1.2\ULN IF LLN \<= PRE-RX \<= ULN; \> 1.5\PRE-RX IF PRE-RX \> ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10\3 C/UL LOW \< 1.5 IF PRE-RX IS MISSING; \< 1.5 IF PRE-RX \>= 1.5; \< 0.85\PRE-RX IF; PRE-RX \< 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10\3 C/UL LOW \< 0.75; HIGH \> 7.5; MONOCYTES (ABSOLUTE) MONOA X10\3 C/UL HIGH \> 2; BASOPHILS (ABSOLUTE) BASOA X10\3 C/UL HIGH \> 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10\3 C/UL HIGH \> 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH \> 1.5\ULN; APTT APTT SEC HIGH \> 1.5\ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH \> 1.5\*ULN;
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.	LIVER \& KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH \> 1.25\ULN IF PRE-RX IS MISSING; \> 1.25\ULN IF PRE-RX \<= ULN; \> 1.25\PRE-RX IF PRE-RX \> ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH \> 1.25\ULN IF PRE-RX IS MISSING; \> 1.25\ULN IF PRE-RX \<= ULN; \> 1.25\PRE-RX IF PRE-RX \> ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH \> 1.25\ULN IF PRE-RX IS MISSING; \> 1.25\ULN IF PRE-RX \<= ULN; \> 1.25\PRE-RX IF PRE-RX \> ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH \> 1.1\ULN IF PRE-RX IS MISSING; \> 1.1\ULN IF PRE-RX \<= ULN; \> 1.25\PRE-RX IF PRE-RX \> ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH \> 1.1\ULN IF PRE-RX IS MISSING; \> 1.1\ULN IF PRE-RX \<= ULN; \> 1.25\PRE-RX IF PRE-RX \> ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH \> 1.1\ULN IF PRE-RX IS MISSING; \> 1.1\ULN IF PRE-RX \<= ULN; \> 1.2\PRE-RX IF PRE-RX \> ULN; CREATININE CREAT MG/DL HIGH \> 1.5\ULN IF PRE-RX IS MISSING; \> 1.5\ULN IF PRE-RX \<= ULN; \> 1.33\*PRE-RX IF PRE-RX \> ULN;
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	ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW \< 0.95\LLN IF PRE-RX IS MISSING; \< 0.95\LLN IF PRE-RX \>= LLN; \< 0.95\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.05\ULN IF PRE-RX IS MISSING; \> 1.05\ULN IF PRE-RX \<= ULN; \> 1.05\PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; POTASSIUM, SERUM K MEQ/L LOW \< 0.9\LLN IF PRE-RX IS MISSING; \< 0.9\LLN IF PRE-RX \>= LLN; \< 0.9\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\ULN IF PRE-RX IS MISSING; \> 1.1\ULN IF PRE-RX \<= ULN; \> 1.1\PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; CHLORIDE, SERUM CL MEQ/L LOW \< 0.9\LLN IF PRE-RX IS MISSING; \< 0.9\LLN IF PRE-RX \>= LLN; \< 0.9\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\ULN IF PRE-RX IS MISSING; \> 1.1\ULN IF PRE-RX \<= ULN; \> 1.1\PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN;
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.	ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW \< 0.9\LLN IF PRE-RX IS MISSING; \< 0.9\LLN IF PRE-RX \>= LLN; \< 0.9\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\ULN IF PRE-RX IS MISSING; \> 1.1\ULN IF PRE-RX \<= ULN; \> 1.1\PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW \< 0.85\LLN IF PRE-RX IS MISSING; \< 0.85\LLN IF PRE-RX \>= LLN; \< 0.85\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.25\ULN IF PRE-RX IS MISSING; \> 1.25\ULN IF PRE-RX \<= ULN; \> 1.25\PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; MAGNESIUM, SERUM MG MEQ/L LOW \< 0.9\LLN IF PRE-RX IS MISSING; \< 0.9\LLN IF PRE-RX \>= LLN; \< 0.9\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\ULN IF PRE-RX IS MISSING; \> 1.1\ULN IF PRE-RX \<= ULN; \> 1.1\PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN
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.	GLUCOSE, FASTING SERUM GLUCF MG/DL LOW \< 0.8\LLN IF PRE-RX IS MISSING; \< 0.8\LLN IF PRE-RX \>= LLN; \< 0.8\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.3\ULN IF PRE-RX IS MISSING \> 1.3\ULN IF PRE-RX \<= ULN; \> 2\PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; PROTEIN, TOTAL TPRO G/DL LOW \< 0.9\LLN IF PRE-RX IS MISSING; \< 0.9\LLN IF PRE-RX \>= LLN; \< 0.9\PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN HIGH \> 1.1\ULN IF PRE-RX IS MISSING; \> 1.1\ULN IF PRE-RX \<= ULN; \> 1.1\PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; ALBUMIN ALB G/DL LOW \< 0.9\LLN IF PRE-RX IS MISSING; \< 0.9\LLN IF PRE-RX \>= LLN; \< 0.9\PRE-RX IF PRE-RX \< LLN; CREATINE KINASE (CK) CK U/L HIGH \> 1.5\ULN IF PRE-RX IS MISSING; \> 1.5\ULN IF PRE-RX \<= ULN; \> 1.5\PRE-RX IF PRE-RX \> ULN; URIC ACID URIC MG/DL HIGH \> 1.2\ULN IF PRE-RX IS MISSING; \> 1.2\ULN IF PRE-RX \<= ULN; \> 1.25\PRE-RX IF PRE-RX \> ULN; LACTATE DEHYDR (LD) LD U/L HIGH \> 1.25\ULN IF PRE-RX IS MISSING; \> 1.25\ULN IF PRE-RX \<= ULN; \> 1.5\PRE-RX IF PRE-RX \> ULN
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.	URINALYSIS I; BLOOD, URINE UBLD N/A HIGH \>= 2 IF PRE-RX IS MISSING; \>= 2 IF PRE-RX \< 1; \>= 2 IF PRE-RX \>= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE
Primary	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Days -3 to -1, Days 1, 5, 8, and 12.	Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Primary	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Days -3 to -1, Days 1, 5, 8, and 12.	Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Primary	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Days -3 to -1, Days 1, 5, 8, and 12.	Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Primary	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Days -3 to -1, Days 1, 5, 8, and 12.	Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Primary	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Days -3 to -1, Days 1, 5, 8, and 12	QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
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
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
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
Secondary	Pharmacokinetic Parameters of BMS-986177: Cmax	Either Day 1, 5, 8, or 12 depending on the randomization sequence	Cmax: Maximum observed plasma concentration
Secondary	Pharmacokinetic Parameters of BMS-986177: Tmax	Either Day 1, 5, 8, or 12 depending on the randomization sequence	Time of maximum observed plasma concentration
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	AUC(0-T) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-24) Area under the plasma concentration-time curve from time zero to 24 hours
Secondary	Pharmacokinetic Parameters of BMS-986177: fu	Either Day 1, 5, 8, or 12 depending on the randomization sequence	Fraction of unbound drug
Secondary	Pharmacokinetic Parameters of BMS-986177: Cmaxfu	Either Day 1, 5, 8, or 12 depending on the randomization sequence	Maximum observed plasma concentration of free drug

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT03000673/registered

API reference For AI assistants

Registered outcomes22

Sources 3

Read this list from software.