Trial · NCT04878731
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 54
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 to Day 42 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event existed at baseline. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL);Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=events with life-threatening consequences, urgent intervention indicated;Grade 5= death related to AE.Treatment-related TEAEs were determined by investigator. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Day 1 to Day 42 | An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. |
| Primary | Number of Participants With Maximum Grade 3 or 4 or 5 TEAEs | Day 1 to Day 42 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event existed in the baseline period. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator. |
| Primary | Number of Participants With TEAEs Leading to Permanent or Temporary Discontinuation From Study | Day 1 to Day 42 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator. |
| Primary | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Day 1 to Day 28 | Laboratory assessments included chemistry, hematology, Prothrombin Time/International Normalized Ratio (PT/INR), Activated Partial Thromboplastin Time (APTT), urinalysis, fibrinogen, Antithrombin III (ATIII) activity, and Cardiac Troponin I (cTnI). Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure. ULN = upper limit of normal. |
| Primary | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | PT is one of the laboratory tests to evaluate the ability of blood clotting. The INR is derived from PT which is calculated as a ratio of a participant's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Participant PT / Control PT. Blood samples were obtained to evaluate PT/INR. |
| Primary | Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | PT is one of the laboratory tests to evaluate the ability of blood clotting. The INR is derived from PT which is calculated as a ratio of a participant's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the WHO using the following formula: INR = Participant PT / Control PT. Blood samples were obtained to evaluate PT/INR. |
| Primary | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | The APTT is a screening test that helps evaluate a person's ability to appropriately form blood clots. It measures the number of seconds it takes for a clot to form in a sample of blood after substances (reagents) are added. Blood samples were obtained to evaluate APTT. |
| Primary | Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | The APTT is a screening test that helps evaluate a person's ability to appropriately form blood clots. It measures the number of seconds it takes for a clot to form in a sample of blood after substances (reagents) are added. Blood samples were obtained to evaluate APTT. |
| Primary | Mean Absolute Value of Fibrinogen | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were obtained to evaluate the amount of fibrinogen. |
| Primary | Change From Baseline in Fibrinogen at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were obtained to evaluate the amount of fibrinogen. |
| Primary | Mean Absolute Value of Antithrombin III (ATIII) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | ATIII is a nonvitamin K-dependent protease that inhibits coagulation by lysing thrombin and factor Xa. The antithrombin activity test measures how well the protein inhibits thrombin, with a reference range of 75% - 125%. Blood samples were obtained to evaluate ATIII activity. |
| Primary | Change From Baseline in ATIII at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | ATIII is a nonvitamin K-dependent protease that inhibits coagulation by lysing thrombin and factor Xa. The antithrombin activity test measures how well the protein inhibits thrombin, with a reference range of 75% - 125%. Blood samples were obtained to evaluate ATIII activity. |
| Primary | Mean Absolute Value of Cardiac Troponin I (cTnI) | Day 1, Day 2, Day 4 | cTnI is one of the cardiac regulatory proteins that control the calcium mediated interaction between actin and myosin, and is considered a specific marker for cardiac damage. Blood samples were obtained to evaluate the amount of cTnI. |
| Primary | Change From Baseline in cTnI at Days 2 and 4 | Baseline (Day 1), Day 2, Day 4 | cTnI is one of the cardiac regulatory proteins that control the calcium mediated interaction between actin and myosin, and is considered a specific marker for cardiac damage. Blood samples were obtained to evaluate the amount of cTnI. |
| Primary | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Day 1 to Day 28 | Vital signs measurements included blood pressure (BP), pulse rate, respiratory rate and oral temperature. Categorical classes for vital signs of potential clinical concern included: (1) systolic BP - minimum (min) value \<90 mmHg, maximum (max) decrease/increase from baseline \>=30 mmHg; (2) diastolic BP - min value \<50 mmHg, max decrease/increase from baseline \>=20 mmHg; (3) supine pulse rate - min \<40 beat per minute (bpm) or max \>120 bpm; (4) standing pulse rate - min \<40 bpm or max \>140 bpm; (5) oral temperature \> 38.5 celsius degree (°C). BPs were measured in a supine position so standing BPs were not evaluated and not reported. |
| Primary | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | BPs were assessed in a supine position with a completely automated device. Categorical classes for supine systolic BP of potential clinical concern included min value \<90 mmHg, max decrease/increase from baseline \>=30 mmHg. |
| Primary | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | BPs were assessed in a supine position with a completely automated device. Categorical classes for supine diastolic BP of potential clinical concern included min value \<50 mmHg, max decrease/increase from baseline \>=20 mmHg. |
| Primary | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Pulse rates were assessed in a supine position with a completely automated device. Categorical classes for supine pulse rate of potential clinical concern included min value \<40 bpm or max value \>120 bpm. |
| Primary | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | No eating, drinking, or smoking was allowed for 15 minutes prior to the measurement of oral temperature. The criterion for oral temperature of potential clinical concern was oral temperature \> 38.5°C. |
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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