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The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKB-6548 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB-6548 | Drug | Different dose levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased. | Baseline; Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Hematocrit on Day 29 | Blood samples were collected to assess hematocrit. A positive change from baseline indicates hematocrit concentration increased. | Baseline; Day 29 |
| Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Akebia Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta | Georgia | United States | ||||
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This study enrolled Chronic Kidney Disease (CKD) Stage 3 or CKD Stage 4 participants. Per protocol, this is a pilot study and all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state as the Sponsor terminated the study early after enrolling 10 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vadadustat | Participants received Vadadustat orally, once daily for 28 days. Participants with Stage 3 and Stage 4 CKD started dosing with 400 milligrams (mg) and 300 mg Vadadustat, respectively. Thereafter, at each of the weekly study visits, dose adjustments were made based on pre-defined dose adjustment algorithm in 100 mg increments allowing a dose range of 200 mg/day to 700 mg/day for Stage 3 CKD participants and 200 mg/day to 600 mg/day for Stage 4 CKD participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set: All participants who received at least 1 dose of study medication. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vadadustat | Participants received Vadadustat orally, once daily for 28 days. Participants with Stage 3 and Stage 4 CKD started dosing with 400 milligrams (mg) and 300 mg Vadadustat, respectively. Thereafter, at each of the weekly study visits, dose adjustments were made based on pre-defined dose adjustment algorithm in 100 mg increments allowing a dose range of 200 mg/day to 700 mg/day for Stage 3 CKD participants and 200 mg/day to 600 mg/day for Stage 4 CKD participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased. | Full Analysis Set: All participants who received at least 1 dose of study medication. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Grams per decilitre (g/dL) | Baseline; Day 29 |
|
Up to 2 weeks post 28 days of treatment
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state.
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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 | Vadadustat | Participants received Vadadustat orally, once daily for 28 days. Participants with Stage 3 and Stage 4 CKD started dosing with 400 milligrams (mg) and 300 mg Vadadustat, respectively. Thereafter, at each of the weekly study visits, dose adjustments were made based on pre-defined dose adjustment algorithm in 100 mg increments allowing a dose range of 200 mg/day to 700 mg/day for Stage 3 CKD participants and 200 mg/day to 600 mg/day for Stage 4 CKD participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
This pilot study planned to include 15 participants with either Stage 3 or 4 CKD, with no minimum or maximum enrollment target for either stage; however, because of slow enrollment the Sponsor terminated the study early after only 10 participants had enrolled. The overall status of the study was considered as completed since 10 participants received Vadadustat and all 10 participants completed the study per protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akebia Therapeutics, Inc | Akebia Therapeutics, Inc | 617-844-6128 | trials@akebia.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C000624313 | vadadustat |
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Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates RBC count increased. |
| Baseline; Day 29 |
| Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 | Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). A positive change from baseline indicates absolute reticulocyte count increased. | Baseline; Day 29 |
| Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 | Blood samples were collected to assess reticulocyte Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates reticulocyte Hgb content increased. | Baseline; Day 29 |
| Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). | Day 29 |
| Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). | Day 29 |
| Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29 | Blood samples were collected to assess hematocrit. | Day 29 |
| Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29 | Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). | Day 29 |
| Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29 | Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). | Day 29 |
| Change From Baseline in Ferritin on Day 29 | Blood samples were collected to assess ferritin. A positive change from baseline indicates ferritin content increased. | Baseline; Day 29 |
| Change From Baseline in Iron on Day 29 | Blood samples were collected to assess iron. A positive change from baseline indicates iron content increased. | Baseline; Day 29 |
| Change From Baseline in Total Iron Binding Capacity on Day 29 | Blood samples were collected to assess total iron binding capacity. A positive change from baseline indicates total iron binding capacity increased. | Baseline; Day 29 |
| Change From Baseline in Transferrin Saturation on Day 29 | Blood samples were collected to assess transferrin saturation. The transferrin saturation is the ratio of the serum iron concentration and the total iron-binding capacity, expressed as a percentage. A positive change from baseline indicates transferrin saturation increased. | Baseline; Day 29 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) was defined as any untoward medical occurrence, signs, symptoms, disease, or laboratory or physiological observations occurring in a participant administered with drug, regardless of a causal relationship with that treatment or usage. This also included all suspected adverse medication reactions, reactions from medication overdose, abuse, withdrawal, sensitivity, toxicity, unrelated illnesses, including worsening a pre-existing condition, injury, or accidents. Serious Adverse Events (SAEs) was defined as any life-threatening condition; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or death. | Up to 2 weeks post 28 days of treatment |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Up to 2 weeks post 28 days of treatment |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Up to 2 weeks post 28 days of treatment |
| Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance. | Up to 2 weeks post 28 days of treatment |
| Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). | Up to 2 weeks post 28 days of treatment |
| Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29 | Serum samples were collected from the participants at the defined time points. Trough concentration was defined as the concentration of drug in the blood immediately before the next dose is administered. Trough concentration was calculated using the validated liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) method | Pre-dose at Day 8, 15, 22 and 29 |
| San Antonio |
| Texas |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Kidney disease stage | Stage 3 CKD: estimated glomerular filtration rate (eGFR) of 30-59 millilitre/minute/1.73 meter square (mL/min/1.73m^2) (moderate kidney damage). Stage 4 CKD: eGFR of < 30 mL/min/1.73m^2; participant was not yet on dialysis and not expected to start dialysis within the next 3 months (severe kidney damage). | Count of Participants | Participants |
|
|
|
|
| Secondary | Mean Change From Baseline in Hematocrit on Day 29 | Blood samples were collected to assess hematocrit. A positive change from baseline indicates hematocrit concentration increased. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Percentage of red blood cells in blood | Baseline; Day 29 |
|
|
|
|
| Secondary | Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 | Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates RBC count increased. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Million cells per cubic millimeter | Baseline; Day 29 |
|
|
|
|
| Secondary | Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 | Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). A positive change from baseline indicates absolute reticulocyte count increased. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Cells per Microlitre | Baseline; Day 29 |
|
|
|
|
| Secondary | Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 | Blood samples were collected to assess reticulocyte Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates reticulocyte Hgb content increased. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Picograms | Baseline; Day 29 |
|
|
|
|
| Secondary | Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Day 29 |
|
|
|
| Secondary | Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Day 29 |
|
|
|
| Secondary | Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29 | Blood samples were collected to assess hematocrit. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Day 29 |
|
|
|
| Secondary | Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29 | Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Day 29 |
|
|
|
| Secondary | Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29 | Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Day 29 |
|
|
|
| Secondary | Change From Baseline in Ferritin on Day 29 | Blood samples were collected to assess ferritin. A positive change from baseline indicates ferritin content increased. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Nanograms per millilitre | Baseline; Day 29 |
|
|
|
|
| Secondary | Change From Baseline in Iron on Day 29 | Blood samples were collected to assess iron. A positive change from baseline indicates iron content increased. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Micrograms per decilitre | Baseline; Day 29 |
|
|
|
|
| Secondary | Change From Baseline in Total Iron Binding Capacity on Day 29 | Blood samples were collected to assess total iron binding capacity. A positive change from baseline indicates total iron binding capacity increased. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Micrograms per decilitre | Baseline; Day 29 |
|
|
|
|
| Secondary | Change From Baseline in Transferrin Saturation on Day 29 | Blood samples were collected to assess transferrin saturation. The transferrin saturation is the ratio of the serum iron concentration and the total iron-binding capacity, expressed as a percentage. A positive change from baseline indicates transferrin saturation increased. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Percentage | Baseline; Day 29 |
|
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) was defined as any untoward medical occurrence, signs, symptoms, disease, or laboratory or physiological observations occurring in a participant administered with drug, regardless of a causal relationship with that treatment or usage. This also included all suspected adverse medication reactions, reactions from medication overdose, abuse, withdrawal, sensitivity, toxicity, unrelated illnesses, including worsening a pre-existing condition, injury, or accidents. Serious Adverse Events (SAEs) was defined as any life-threatening condition; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or death. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Up to 2 weeks post 28 days of treatment |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Up to 2 weeks post 28 days of treatment |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Up to 2 weeks post 28 days of treatment |
|
|
|
| Secondary | Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance. | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Count of Participants | Participants | Up to 2 weeks post 28 days of treatment |
|
|
|
| Secondary | Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | Milliseconds | Up to 2 weeks post 28 days of treatment |
|
|
|
| Secondary | Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29 | Serum samples were collected from the participants at the defined time points. Trough concentration was defined as the concentration of drug in the blood immediately before the next dose is administered. Trough concentration was calculated using the validated liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) method | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Posted | Mean | Standard Deviation | nanograms per millilitre | Pre-dose at Day 8, 15, 22 and 29 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Change from baseline ≥ 1.0 grams per decilitre |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Change from Baseline QT Interval |
|
| Baseline QRS Interval |
|
| Change from Baseline QRS Interval |
|
| Baseline QTC Interval |
|
| Change from Baseline QTC Interval |
|
| Title | Measurements |
|---|---|
|
| Day 29 |
|