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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.
This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.
An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy.
Overall response rates as well as individual categories of response complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) will be determined using RECIST 1.1. Time-to-event endpoints, including progression-free survival (PFS) and overall survival (OS) will be assessed using the Kaplan-Meier method. Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 5.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine) | Experimental | nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine) | Drug | Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days. Gemcitabine 1000mg/m2 in 500 mL* over 30 minute IV infusion on days 1 and 8 repeated every 21 days. Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered on days 1 and 8 repeated every 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 12- Month Overall Survival (OS) | Evaluate the 12-month OS rate in patients with metastatic Pancreatic ductal adenocarcinoma (PDA) treated with nab-paclitaxel plus cisplatin plus gemcitabine | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity Adverse Events (Grade ≥ 3) | Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per event term), n (%) | 12-months |
| Complete Response Rate (CR) |
Not provided
Inclusion Criteria:
Age ≥ 18 years of age; male or female
Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
Capable of providing informed consent and complying with trial procedures.
Karnofsky Performance Status (KPS) of ≥ 70%.
Life expectancy ≥ 12 weeks.
Measurable tumor lesions according to RECIST 1.1 criteria.
< Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
Patient has acceptable coagulation status as indicated by an international normalized ratio (INR) ≤1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
Patients must have normal organ and marrow function as defined below:
Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation from study treatment, even if he has undergone a successful vasectomy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gayle Jameson, ACNP-BC | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of Miami |
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| ID | Title | Description |
|---|---|---|
| FG000 | NabCG | nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days nab-Paclitaxel + Cisplatin + Gemcitabine: Cisplatin 25mg/m2 in 500 mL of normal saline (NS) over 60 minute IV infusion on days 1 and 8 repeated every 21 days. Gemcitabine 1000mg/m2 in 500 mL* over 30 minute IV infusion on days 1 and 8 repeated every 21 days. Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered on days 1 and 8 repeated every 21 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NabCG | nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days nab-Paclitaxel + Cisplatin + Gemcitabine: Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days. Gemcitabine 1000mg/m2 in 500 mL* over 30 minute IV infusion on days 1 and 8 repeated every 21 days. Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered on days 1 and 8 repeated every 21 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 12- Month Overall Survival (OS) | Evaluate the 12-month OS rate in patients with metastatic Pancreatic ductal adenocarcinoma (PDA) treated with nab-paclitaxel plus cisplatin plus gemcitabine | Posted | Count of Participants | Participants | 12 months |
|
36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
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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 | NabCG | nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days nab-Paclitaxel + Cisplatin + Gemcitabine: Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days. Gemcitabine 1000mg/m2 in 500 mL* over 30 minute IV infusion on days 1 and 8 repeated every 21 days. Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered on days 1 and 8 repeated every 21 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Immune system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gayle Jameson, MSN, ACNP-BC, AOCN | HonorHealth Research Institute | 4803231350 | clinicaltrials@honorhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2021 | Oct 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2021 | Oct 30, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
|
Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN). |
| 63 days |
| Disease Control Rate (CR, PR, SD) at 9 Weeks | To determine the preliminary efficacy (Disease control rate of CR+ PR+SD X 9 weeks) of the combination of nanoparticle albumin- bound paclitaxel + cisplatin + gemcitabine (NABPLAGEM) in patients with stage IV metastatic pancreatic cancer.complete response rate( RECIST 1.1), disease control rate at 9 weeks, Change and rates of normalization in CA 19-9 (or Ca125 or CEA if not expressers of CA 19-9) | 63 days |
| Change in CA 19-9 or CA 125 | Change in carbohydrate antigen 19-9 (CA 19-9) or cancer antigen 125 (CA 125). Both CA 19-9 and CA 125 are markers of tumor burden and treatment response. | End of Study (36 months) |
| Rate of Tumor Marker Normalization | Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN). | 12 months |
| Quality of Life: MD Anderson Symptom Inventory (MDASI-GI) | The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) is a site-specific MDASI module. Along with the core MDASI's 13 symptom items and 6 interference items, the MDASI-GI also assesses 5 symptoms specific to gastrointestinal cancer. Average Symptom severity Scores were measured to assess change in symptoms over time (Core Symptom Scoring: 0 - Not Present to 10 - As Bad as you can imagine; Overall symptom distress (Interference) Scoring: 0-Did not interfere to 10-Interfeard completely; Gastrointestinal Module: 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be)). | Baseline to Midpoint (C4/D1) |
| Pain Control: Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The BPI has been translated into dozens of languages, and it is widely used in both research and clinical settings. Average scores were measured (Scoring scale: Pain Severity: 0 - No Pain to 10 - Pain as bad as you can imagine; Pain Interference 0-Does not interfere to 10 - Completely Interferes) | Baseline to Midpoint (C4/D1) |
| Miami |
| Florida |
| 33136 |
| United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| KPS - Karnofsky Performance Status | The Karnofsky Performance Scale Index allows patients to be graded and classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. The higher Karnofsky score, indicates Normal, no complaints in functional impairment. | Count of Participants | Participants |
|
| Tumor Markers cancer antigen (CA) 19-9 (or CA 125, or CEA) | CA 19-9 is a tumor marker that provides important clues about the presence and progression of cancer. In healthy individuals, the normal CA 19-9 range is between 0 and 37 units per milliliter (U/mL). CA 125 levels help assess treatment response and evaluate recurrence. CA-125 levels in the body are measured in units per milliliter (U/mL). A CA-125 normal range falls between 0 and 35 U/mL. CEA (Carcinoembryonic Antigen), indicates whether cancer is growing or diminishing with treatment. The reference range for CEA is 0 to 2.9 ng/mL of blood. * 2 participants were expressors of CA 125 and CEA. | Count of Participants | Participants |
|
| Primary tumor location on pancreas | Count of Participants | Participants |
|
| Prior Cancer Treatment | Count of Participants | Participants |
|
| Neutrophil-to-lymphocyte ratio (NLR) | NLR is calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. The calculation reflects the balance between neutrophils (a type of white blood cell involved in inflammation) and lymphocytes (another type of white blood cell that plays a role in immune response). | Count of Participants | Participants |
|
| MD Anderson's Symptom Inventory-GI (MDASI-GI) | MDASI-GI is a site-specific MDASI module. Along with the core MDASI's 13 symptom items and 6 interference items, the MDASI-GI also assesses 5 symptoms specific to gastrointestinal cancer. Average Symptom severity Scores measured to assess change in symptoms over time (Core Symptom Scoring: 0 - Not Present to 10 - As Bad as you can imagine; Overall symptom distress (Interference) Scoring: 0-Did not interfere to 10-Interfeard completely; Gastrointestinal Module: 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be)). | Mean | Standard Deviation | symptom score |
|
| Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The BPI has been translated into dozens of languages, and it is widely used in both research and clinical settings. Average scores were measured (Scoring scale: Pain Severity: 0 - No Pain to 10 - Pain as bad as you can imagine; Pain Interference 0-Does not interfere to 10 - Completely Interferes) | Mean | Standard Deviation | pain score |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Toxicity Adverse Events (Grade ≥ 3) | Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per event term), n (%) | Posted | Count of Participants | Participants | 12-months |
|
|
|
| Secondary | Complete Response Rate (CR) | Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN). | A total of 36 participants had one or more follow-up scans available for tumor assessment, plus one additional patient had documented clinical disease progression before any follow-up scan occurred. Of these 37, 0 (0.0%) had complete response (CR), regardless of normalized CA 19-9 (one-sided 97.5% Confidence interval (CI), 0.0-9.5%). | Posted | Number | 97.5% Confidence Interval | percentage of participants | 63 days |
|
|
|
| Secondary | Disease Control Rate (CR, PR, SD) at 9 Weeks | To determine the preliminary efficacy (Disease control rate of CR+ PR+SD X 9 weeks) of the combination of nanoparticle albumin- bound paclitaxel + cisplatin + gemcitabine (NABPLAGEM) in patients with stage IV metastatic pancreatic cancer.complete response rate( RECIST 1.1), disease control rate at 9 weeks, Change and rates of normalization in CA 19-9 (or Ca125 or CEA if not expressers of CA 19-9) | A total of 34 participants had follow-up scans available for tumor assessment at 9 weeks, plus one additional participant had documented clinical disease progression before any follow-up scan occurred. Of these 35, 0 achieved complete response (CR), 12 (34.3%; 95% CI, 19.1-52.2%) achieved partial response (PR), and 19 (54.3%; 95% CI, 36.6-71.2%) achieved stable disease (SD), yielding a total of 31 (88.6%; 95% CI, 73.3-96.8%) for the disease control rate at 9 weeks. | Posted | Count of Participants | Participants | 63 days |
|
|
|
| Secondary | Change in CA 19-9 or CA 125 | Change in carbohydrate antigen 19-9 (CA 19-9) or cancer antigen 125 (CA 125). Both CA 19-9 and CA 125 are markers of tumor burden and treatment response. | Of 42 participants with tumor marker data, n=35 expressed CA 19-9 (> 35 U/mL). Of the remaining participants, n=5 expressed CA 125, and n=3 did not express CA 19-9 or CA 125 and were excluded from this analysis. End-of-study is defined as the last available measure after baseline. | Posted | Median | Inter-Quartile Range | U/mL | End of Study (36 months) |
|
|
|
|
| Secondary | Rate of Tumor Marker Normalization | Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN). | There were 36 participants whose baseline tumor marker levels were twice the upper limit of normal and could therefore be included in this analysis. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Quality of Life: MD Anderson Symptom Inventory (MDASI-GI) | The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) is a site-specific MDASI module. Along with the core MDASI's 13 symptom items and 6 interference items, the MDASI-GI also assesses 5 symptoms specific to gastrointestinal cancer. Average Symptom severity Scores were measured to assess change in symptoms over time (Core Symptom Scoring: 0 - Not Present to 10 - As Bad as you can imagine; Overall symptom distress (Interference) Scoring: 0-Did not interfere to 10-Interfeard completely; Gastrointestinal Module: 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be)). | In a linear mixed-model average Core symptom severity, overall symptom distress (interference), and average gastrointestinal module were assessed for change. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline to Midpoint (C4/D1) |
|
|
|
|
| Secondary | Pain Control: Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The BPI has been translated into dozens of languages, and it is widely used in both research and clinical settings. Average scores were measured (Scoring scale: Pain Severity: 0 - No Pain to 10 - Pain as bad as you can imagine; Pain Interference 0-Does not interfere to 10 - Completely Interferes) | In a linear mixed-model, average Pain severity and average Pain interference were measured to assess change. | Posted | Median | Inter-Quartile Range | change in pain score | Baseline to Midpoint (C4/D1) |
|
|
|
|
| Post-Hoc | 18 - Month Overall Survival | Evaluate the 18-month OS rate in patients with metastatic PDA treated with nab-paclitaxel plus cisplatin plus gemcitabine | Posted | Count of Participants | Participants | 18 months |
|
|
|
| 37 |
| 42 |
| 28 |
| 42 |
| 42 |
| 42 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Viremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pulmonary embolism | Cardiac disorders | Systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Biliary tract infection | Gastrointestinal disorders | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | Systematic Assessment |
|
| Bacteremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Rectal ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Gait Distrubance | General disorders | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| White blood cell decreased | Investigations | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| Gastrointestinal disorders - Enterocolitis : Total |
|
| Gastrointestinal disorders - Mucositis oral : Total |
|
| General disorders and administration site conditions - Fatigue : Total |
|
| General disorders and administration site conditions - Gait disturbance : Total |
|
| Infections and infestations - skin infestations : Total |
|
| Investigations - Lymphocyte count decreased : Total |
|
| Investigations - Neutrophil count decreased : Total |
|
| Investigations - Platelet count decreased : Total |
|
| Investigations - White blood cell decreased : Total |
|
| Metabolism and nutrition disorders - Anorexia : Total |
|
| Metabolism and nutrition disorders - Hypocalcemia : Total |
|
| Metabolism and nutrition disorders - Hypokalemia : Total |
|
| Metabolism and nutrition disorders - Hyponatremia : Total |
|
| Musculoskeletal and connective tissue disorders - Generalized muscle weakness : Total |
|
| Nervous system disorders - Peripheral sensory neuropathy : Total |
|
| Renal and urinary disorders - Acute kidney injury : Total |
|
| Title | Measurements |
|---|---|
|
|
| 0.438 |
| Other |
Wilcoxon signed-rank test |
|
| 0.048 |
| Other |
Wilcoxon signed-rank test |
| Gastrointestinal module | Wilcoxon signed-rank test | 0.437 | Other | Wilcoxon signed-rank test |
| 0.032 |
| Other |
Wilcoxon signed-rank test |