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The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.
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The purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (PF-07081532). People with certain level of kidney functional impairment may process PF-07081532 differently from healthy people. PF-07081532 is developed as a potential treatment for type II diabetes.
Participants will take the study medicine as a tablet by mouth once at the study clinic and then will stay at the study clinic for about 7 days. During that time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain degree of kidney functional impairment will have an effect on the study medicine PF-07081532.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants without renal impairment will receive a single 20 mg dose of PF 07081532, administered orally |
|
| Group 2 | Experimental | Participants with mild renal impairment will receive a single 20 mg dose of PF 07081532, administered orally |
|
| Group 3 | Experimental | Participants with moderate renal impairment will receive a single 20 mg dose of PF 07081532, administered orally |
|
| Group 4 | Experimental | Participants with severe renal impairment will receive a single 20 mg dose of PF 07081532, administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07081532 | Drug | One PF-07081532 20 mg tablet, administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | Plasma Cmax was observed directly from data. | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
| Unbound Cmax (Cmax,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | Cmax,u was calculated as fu*Cmax. Plasma Cmax was observed directly from data. fu was defined as the fraction of unbound drug in plasma, and was obtained from measurement of protein binding. | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | AUCinf was calculated as AUClast + (Clast*/kel). AUClast was defined as area under the plasma concentration-time profile from time 0 to the time last measurable concentration, and was calculated using linear/log trapezoidal method. Clast* was defined as the predicted plasma concentration at the last quantifiable time point estimated from log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
| Unbound AUCinf (AUCinf,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | AUCinf,u was calculated as fu*AUCinf. AUCinf was calculated as AUClast + (Clast*/kel). AUClast was defined as area under the plasma concentration-time profile from time 0 to the time last measurable concentration, and was calculated using linear/log trapezoidal method. Clast* was defined as the predicted plasma concentration at the last quantifiable time point estimated from log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. fu was the fraction of unbound drug in plasma, and was obtained from measurement of protein binding. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent AEs (TEAEs) = AEs occurred after starting of study treatment and up to the end of study that were absent before treatment or that worsened relative to pretreatment state. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Severe=an event that prevents normal everyday activities. |
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Inclusion Criteria:
Stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of BSA-unnormalized eGFR
A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%
Women may be of child-bearing potential
BMI of 17.5 to 45.4 kg/m2
NORMAL FUNCTION (GROUP 1): Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2 (eGFR should be calculated using the 2021 CKD EPI Scr-Scys combined equation:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Clinical Research, LLC | Tampa | Florida | 33603 | United States | ||
| Prism Research LLC dba Nucleus Network |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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The study was terminated due to the termination of clinical development of PF-07081532. As of the last participant last visit (LPLV) date (20 Jul 2023), a total of 18 participants were enrolled at 2 sites in the United States, and no participants without renal impairment were enrolled due to early study termination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild Renal Impairment | Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally. |
| FG001 | Moderate Renal Impairment | Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally. |
| FG002 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants assigned to study intervention and who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Renal Impairment | Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally. |
| BG001 | Moderate Renal Impairment | Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | Plasma Cmax was observed directly from data. | Pharmacokinetic (PK) parameter set included all participants who received at least 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
|
From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild Renal Impairment | Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
The study was terminated due to the termination of clinical development of PF-07081532, and no participants without renal impairment were enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2022 | Jul 19, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2022 | Jul 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
| Unbound Fraction (fu) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | fu was the ratio of unbound drug concentration to the total drug concentration, and was obtained from measurement of protein binding. | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
| From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose) |
| Number of Participants With Laboratory Test Abnormalities | Parameters analyzed for lab examination included hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin [MCH], MCH concentration, platelet count, white blood cell count, absolute [Abs] total neutrophils, Abs eosinophils, Abs monocytes, Abs basophils, Abs lymphocytes), chemistry (Scr, Scys, fasting plasma glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl eGFR), urinalysis (pH, qualitative [qual] glucose, qual protein, qual blood, ketones, nitrites, leukocyte, esterase, urobilinogen, urine bili, microscopy). Lab parameters meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study are reported. Baseline was defined as the last pre-dose measurement. | Pre-dose, 72 and 144 hours post dose on Day 1 |
| Number of Participants With Vital Signs Data Meeting Pre-Defined Categorical Criteria | Vital signs including single, seated blood pressure (BP) and pulse rate were measured with the participant's arm supported at the level of the heart, and recorded to the nearest mmHg, following a seated rest of ≥5 minutes. Same arm (preferably the dominant arm) was used for BP/pulse rate assessment throughout the study. Vital signs meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study are reported. Baseline was defined as the last pre-dose measurement. | At admission on Day -1, pre-dose, and 24, 72, and 144 hours post the dose on Day 1 |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Defined Categorical Criteria | Supine standard 12-lead ECGs utilizing limb leads (with a 10-second rhythm strip) were collected at times specified in the time frame using an ECG machine that automatically calculates the HR and measures PR interval, QT interval, QTcF, and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. ECG data meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study were reported. Baseline was defined as the last pre-dose measurement. | Pre-dose, and 144 hours post the dose on Day 1 |
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| BG002 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI= {Weight (kilograms [kg])} / {height (centimeters [cm] )*0.01}^2 | Mean | Standard Deviation | kg/m^2 |
|
| Body Surface Area (BSA)-Unnormalized Estimated Glomerular Filtration Rate (eGFR) | BSA-Normalized eGFR was calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) serum creatinine (Scr) - serum cystatin C (Scys) Combined Equation. Average of the measurements at screening visits S1 and S2 were used in analyses. For participants on dialysis, screening visit S2 was optional. BSA=[weight (kg)^0.425 * height (cm)^0.725]*0.007184. BSA-Unnormalized eGFR=BSA-Normalized eGFR (mL/min/1.73m^2) * [BSA (m^2) /1.73]. | Mean | Standard Deviation | Milliliters per minute (mL/min) |
|
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally. |
| OG002 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally. |
|
|
| Primary | Unbound Cmax (Cmax,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | Cmax,u was calculated as fu*Cmax. Plasma Cmax was observed directly from data. fu was defined as the fraction of unbound drug in plasma, and was obtained from measurement of protein binding. | PK parameter set included all participants who received at least 1 dose of PF-07081532 and had at least 1 of PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
|
|
|
| Primary | Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | AUCinf was calculated as AUClast + (Clast*/kel). AUClast was defined as area under the plasma concentration-time profile from time 0 to the time last measurable concentration, and was calculated using linear/log trapezoidal method. Clast* was defined as the predicted plasma concentration at the last quantifiable time point estimated from log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | PK parameter set included all participants, who received at least 1 dose of PF-07081532, had at least 1 of PK parameters of interest calculated. Number of Participants Analyzed represents the number of participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hours/milliliter (ng*h/mL) | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
|
|
|
| Primary | Unbound AUCinf (AUCinf,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | AUCinf,u was calculated as fu*AUCinf. AUCinf was calculated as AUClast + (Clast*/kel). AUClast was defined as area under the plasma concentration-time profile from time 0 to the time last measurable concentration, and was calculated using linear/log trapezoidal method. Clast* was defined as the predicted plasma concentration at the last quantifiable time point estimated from log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. fu was the fraction of unbound drug in plasma, and was obtained from measurement of protein binding. | PK parameter set included all participants, who received at least 1 dose of PF-07081532, had at least 1 of PK parameters of interest calculated. Number of Participants Analyzed represents the number of participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
|
|
|
| Primary | Unbound Fraction (fu) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment | fu was the ratio of unbound drug concentration to the total drug concentration, and was obtained from measurement of protein binding. | PK parameter set included all participants who received at least 1 dose of PF-07081532 and had at least 1 of PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1 |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent AEs (TEAEs) = AEs occurred after starting of study treatment and up to the end of study that were absent before treatment or that worsened relative to pretreatment state. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Severe=an event that prevents normal everyday activities. | Safety analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose) |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities | Parameters analyzed for lab examination included hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin [MCH], MCH concentration, platelet count, white blood cell count, absolute [Abs] total neutrophils, Abs eosinophils, Abs monocytes, Abs basophils, Abs lymphocytes), chemistry (Scr, Scys, fasting plasma glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl eGFR), urinalysis (pH, qualitative [qual] glucose, qual protein, qual blood, ketones, nitrites, leukocyte, esterase, urobilinogen, urine bili, microscopy). Lab parameters meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study are reported. Baseline was defined as the last pre-dose measurement. | Safety analysis set included all participants assigned to study intervention who took at least 1 dose of study intervention. Number of Participants Analyzed represents the total number of participants who were evaluable for this outcome measure. Number Analyzed for each lab parameter represents the number of participants who had at least 1 post dose measurement for the parameter. | Posted | Count of Participants | Participants | Pre-dose, 72 and 144 hours post dose on Day 1 |
|
|
|
| Secondary | Number of Participants With Vital Signs Data Meeting Pre-Defined Categorical Criteria | Vital signs including single, seated blood pressure (BP) and pulse rate were measured with the participant's arm supported at the level of the heart, and recorded to the nearest mmHg, following a seated rest of ≥5 minutes. Same arm (preferably the dominant arm) was used for BP/pulse rate assessment throughout the study. Vital signs meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study are reported. Baseline was defined as the last pre-dose measurement. | Safety analysis set included all participants assigned to study intervention who took at least 1 dose of study intervention. Number of Participants Analyzed represents the total number of participants who were evaluable for this outcome measure. Number Analyzed for each lab parameter represents the number of participants who had at least 1 post dose measurement for the parameter. | Posted | Count of Participants | Participants | At admission on Day -1, pre-dose, and 24, 72, and 144 hours post the dose on Day 1 |
|
|
|
| Secondary | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Defined Categorical Criteria | Supine standard 12-lead ECGs utilizing limb leads (with a 10-second rhythm strip) were collected at times specified in the time frame using an ECG machine that automatically calculates the HR and measures PR interval, QT interval, QTcF, and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. ECG data meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study were reported. Baseline was defined as the last pre-dose measurement. | Safety analysis set included all participants assigned to study intervention who took at least 1 dose of study intervention. Number of Participants Analyzed represents the total number of participants who were evaluable for this outcome measure. Number Analyzed for each lab parameter represents the number of participants who had at least 1 post dose measurement for the parameter. | Posted | Count of Participants | Participants | Pre-dose, and 144 hours post the dose on Day 1 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Moderate Renal Impairment | Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG002 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally. | 0 | 8 | 0 | 8 | 1 | 8 |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
|
| Participants With All-Causality Severe TEAEs |
|
| Participants With Treatment-Related TEAEs |
|
| Participants With Treatment-Related SAEs |
|
| Participants With Treatment-Related Severe TEAEs |
|
| Hematology-Hematocrit (%)<0.8*LLN |
|
|
| Hematology-Erythrocytes (10^12/Liter [L])<0.8*LLN |
|
|
| Hematology-Eosinophils (10^9/L)>1.2* upper limit of normal (ULN) |
|
|
| Clinical Chemistry-Gamma Glutamyl Transferase (units [U]/L)>3.0*ULN |
|
|
| Clinical Chemistry-Urea Nitrogen (milligrams [mg] / dL)>1.3*ULN |
|
|
| Clinical Chemistry-Creatinine (mg/dL)>1.3*ULN |
|
|
| Clinical Chemistry-Urate (mg/dL)>1.2*ULN |
|
|
| Clinical Chemistry-Potassium (milliequivalents [mEq] / L)>1.1*ULN |
|
|
| Clinical Chemistry-Magnesium (mg/dL)<0.9*LLN |
|
|
| Clinical Chemistry-Phosphate (mg/dL)<0.8*LLN |
|
|
| Clinical Chemistry-Phosphate (mg/dL)>1.2*ULN |
|
|
| Clinical Chemistry-Bicarbonate (mEq/L)<0.9*LLN |
|
|
| Clinical Chemistry-Fasting Glucose (mg/dL)>1.5*ULN |
|
|
| Urinalysis-Urine Glucose Positive |
|
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| Urinalysis-Urine Protein Positive |
|
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| Urinalysis-Urine Hemoglobin Positive |
|
|
| Urinalysis-Nitrite Positive |
|
|
| Urinalysis-Leukocyte Esterase Positive |
|
|
| Diastolic BP (mm Hg) Increase >=20 mm Hg |
|
|
| Diastolic BP (mm Hg) Decrease >=20 mm Hg |
|
|