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Myasthenia Gravis

Muscle Weakness

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All Drugs and Chemicals

Eculizumab

Complement System Proteins

Immunosuppressive Agents

Immunologic Factors

In the Primary Evaluation Treatment Period (26 weeks), eculizumab will be administered weekly during the initial induction phase and every 2 weeks during the maintenance phase.

In the Extension Period (up to 208 weeks), participants will continue to receive eculizumab every 2 weeks.

Eculizumab will be administered at doses of 300, 600, 900, or 1200 milligrams (mg), based on the participant's current body weight.

Eculizumab will be administered by IV infusion.

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis (QMG) score for disease severity.

The study will consist of an up to 4-week Screening Period, 26-week Primary Evaluation Treatment Period, an additional (up to) to 208-week Extension Period, and an 8-week Safety Follow-up Period.

A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients With Refractory Generalized Myasthenia Gravis

The QMG scoring system consists of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item is graded from 0 to 3, (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The range of total QMG score is 0 to 39, with higher score indicating more severe disease.

The MG-ADL is an 8-point questionnaire that focuses on relevant symptoms and functional performance of activities of daily living in participants with myasthenia gravis (MG). The 8 items of the MG-ADL are derived from symptom-based components of the original 13-item QMG to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response is graded from 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 to 24, with higher score indicating more severe disease.

The MG-ADL is an 8-point questionnaire that focuses on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MG-ADL are derived from symptom-based components of the original 13-item QMG to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response is graded from 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 to 24, with higher score indicating more severe disease.

The MGC is a validated assessment tool for measuring clinical status of participants with MG. The MGC assesses 10 important functional areas most frequently affected by MG: ocular (2 items), facial (1 item), bulbar (3 items), respiratory (1 item), axial (1 item), and gross motor (2 items). The scales are weighted for clinical significance that incorporates patient-reported outcomes. The MGC total score ranges from 0 to 50, with lower scores indicating less functional impairment and higher scores indicating greater functional impairment.

The EQ-5D-Y is a reliable and validated survey of health status in 5 areas: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which is completed by the participant for participants ≥12 years of age (at time of assessment) and completed by the participant's caregiver or with caregiver assistance for participant \<12 years of age. Each area has 3 levels: Level 1 (no problems), Level 2 (some problems), and Level 3 (extreme problems). The EQ visual analogue scale (VAS) records the participant's self-rated health on a vertical, 20 cm VAS where the endpoints are labelled 'Best imaginable health state, marked as 100' and 'Worst imaginable health state, marked as 0'.

The Neuro-QoL Pediatric Fatigue questionnaire is a reliable and validated brief 11-item survey of fatigue, completed by the participant for participants ≥12 years of age (at time of assessment) and completed by the participant's caregiver or with caregiver assistance for participants \<12 years of age. Each item was scored on a scale of 1 to 5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Total score is the sum of each item's score and it ranges from 11 to 55. Higher scores indicate greater fatigue and greater impact of MG on activities.

The MG clinical state (improved, unchanged, and worse) was assessed using the MGFAPIS.

Rescue therapy (for example, high dose corticosteroid, plasma exchange \[PE\], or intravenous immunoglobulin \[IVIg\]) was to be allowed when a participant experienced clinical deterioration. Clinical deterioration was defined as follows: Participants who experienced an MG crisis, which was defined as weakness due to MG that was severe enough to necessitate intubation or to delay extubation following surgery; or, Significant symptomatic worsening that required rescue medication in the opinion of the Investigator; or, Participants for whom the Investigator believed that the participants' health was in jeopardy if rescue therapy was not given.

Alexion Pharmaceuticals, Inc.

Safety analysis set included all participants who received at least 1 dose of eculizumab.

Participants received eculizumab weekly by IV infusion during the Primary Evaluation Treatment Period (26 weeks) and the Extension Period (up to 208 weeks). Dosing was initiated with a weekly weight-based induction regimen (Induction Phase) and, thereafter, participants were dosed every 2 weeks (Maintenance Phase). Eculizumab was administered at doses of 300, 600, 900, or 1200 mg, based on the participant's current body weight.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

The QMG scoring system consists of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item is graded from 0 to 3, (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The range of total QMG score is 0 to 39, with higher score indicating most severe disease.

QMG Total Score

Full analysis set included all participants who received at least 1 dose of eculizumab.

Modified full analysis set (mFAS) included participants 12 to \<18 years of age who received at least 1 dose of eculizumab. Overall number of participants analyzed = participants evaluable for this outcome measure.

Change From Baseline in the QMG Total Score at Week 26 Regardless of Rescue Treatment

mFAS included participants 12 to \<18 years of age who received at least 1 dose of eculizumab. Overall number of participants analyzed = participants evaluable for this outcome measure.

Change From Baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score at Week 26 Regardless of Rescue Treatment

Percentage of Participants With ≥3-Point Reduction in the MG-ADL Total Score With No Rescue Treatment

Percentage of Participants With ≥3-Point Reduction in the MG-ADL Total Score Regardless of Rescue Treatment

Percentage of Participants With ≥5-Point Reduction in the QMG Total Score With No Rescue Treatment

Percentage of Participants With ≥5-Point Reduction in the QMG Total Score Regardless of Rescue Treatment

Change From Baseline in the Myasthenia Gravis Composite (MGC) Scale Total Score at Week 26 Regardless of Rescue Treatment

Change From Baseline in the European Quality of Life 5-Dimension Youth Version (EQ-5D-Y) Scale Score at Week 26 Regardless of Rescue Treatment

Change From Baseline in the Neurological Quality of Life-Fatigue Questionnaire (Neuro-QoL Pediatric Fatigue) Total Score at Week 26 Regardless of Rescue Treatment

Number of Participants in Each Category of the Myasthenia Gravis Foundation of America Post-Intervention Status (MGFAPIS) Regardless of Rescue Treatment at Week 26

Clinical Deterioration

MG Crisis

Requiring Rescue Therapy

mFAS included participants 12 to \<18 years of age who received at least 1 dose of eculizumab.

Percentage of Participants With Clinical Deteriorations, Myasthenic Crises, and Rescue Therapy Use

Day 1, 24 hours postdose (n = 11)

Week 12, Predose

Week 12, 60 minutes postdose

Week 26, Predose

PK analysis set included participants who had PK data assessments during this study. Here, number analyzed = participants evaluable at specified timepoint.

Pharmacokinetics (PK): Serum Concentration Of Eculizumab

Baseline

Day 1, 24 hours postdose

PD analysis set included participants who had PD data assessments during this study. Here, number analyzed = participants evaluable at specified timepoint.

Pharmacodynamics (PD): Serum Free Complement Component 5 (C5) Concentrations

PD analysis set included participants who had PD data assessments during this study. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed = participants evaluable at specified timepoint.

PD: Percentage of Hemolysis (In Vitro Assay)

Participants received eculizumab weekly by intravenous (IV) infusion during the Primary Evaluation Treatment Period (26 weeks) and the Extension Period (up to 208 weeks). Dosing was initiated with a weekly weight-based induction regimen (Induction Phase) and, thereafter, participants were dosed every 2 weeks (Maintenance Phase). Eculizumab was administered at doses of 300, 600, 900, or 1200 milligrams (mg), based on the participant's current body weight.

Primary Evaluation Period (26 Weeks)

Extension Period (Up to 208 Weeks)

Vaccines

Biological/Vaccine: Eculizumab; Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4); Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26).

Placebo contains the same buffer components without the active ingredient; Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4); Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26).

Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26

Placebo

The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

In the Worst-Rank analysis, the 125 total patients were ranked from best outcome (rank/score of 1) to worst outcome (rank/score of 125).

Induction phase: 3 vials of study drug (equivalent to 900 mg of eculizumab) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (equivalent to 1200 mg of eculizumab) 1 week later for the fifth dose (Week 4).

Maintenance phase: 4 vials of study drug (equivalent to 1200 mg of eculizumab) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26).

Induction phase: 3 vials of study drug (placebo) weekly for 4 doses (every 7 days ± 2 days) followed by 4 vials of study drug (placebo) 1 week later for the fifth dose (Week 4).

Maintenance phase: 4 vials of study drug (placebo) every 2 weeks (14 days ± 2 days) from the fifth dose onwards (Week 6 through Week 26).

Total

Jing-Jing Wang, MD

Myasthenia Gravis Activities of Daily Living Profile (MG-ADL): Change From Baseline in MG-ADL Total Score at Week 26 by Worst-Rank Analysis of Covariance (ANCOVA)

Overall Study

Blood and Lymph Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hemoglobinuria

Hemoglobinuria, Paroxysmal

Neoplasms by Histologic Type

Hematologic Diseases

Proteinuria

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urological Manifestations

Anemia

Hemolysis

Anemia, Hemolytic

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Paroxysmal Nocturnal Hemoglobinuria

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Micronutrients

Anti-Infective Agents

Chrysarobin

Iodine

eculizumab

Ronald Paquette, MD

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eculizumab may prevent leukemia and stop the destruction of red blood cells in patients with paroxysmal nocturnal hemoglobinuria.

PURPOSE: This randomized phase III trial is studying how well eculizumab works in treating patients with paroxysmal nocturnal hemoglobinuria.

OBJECTIVES:

Primary

* Determine the safety of eculizumab in patients with transfusion-dependent hemolytic paroxysmal nocturnal hemoglobinuria.
* Determine the efficacy of this drug, in terms of hemoglobin stabilization and the number of packed red blood cell units transfused during the 26-week treatment period, in these patients.

Secondary

* Compare the occurrence of transfusion avoidance, hemolysis (measured by lactate dehydrogenase \[LDH\] area under the curve), and the changes in fatigue during the 26-week treatment period in patients treated with this drug vs placebo.
* Compare LDH changes, quality of life changes, thrombosis, platelet activity, nitric oxide, and free hemoglobin measures during the 26-week treatment period in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of packed red blood cell (PRBC) units transfused 1 year prior to screening (\< 15 units vs 15-25 units vs \> 25 units). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Within 10 days after PRBC transfusion (administered during the study observation period), patients receive placebo IV over 30 minutes once a week for 5 weeks and then once every 2 weeks for 21 weeks.
* Arm II: Within 10 days after PRBC transfusion (administered during the study observation period), patients receive eculizumab IV over 30 minutes once a week for 5 weeks and then once every 2 weeks for 21 weeks.

Quality of life is assessed at baseline; at weeks 0-4, 12, 20, and 26 during study treatment; then at weeks 1, 2, 4, and 8 after completion of study treatment.

After completion of study treatment, patients are followed at weeks 1, 2, 4, and 8.

PROJECTED ACCRUAL: Approximately 75 patients (37 per treatment arm) will be accrued for this study.

Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria

TRIUMPH: A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

Jonsson Comprehensive Cancer Center

Oculocerebral Syndrome With Hypopigmentation

eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses

Placebo IV weekly for 4 doses then every two weeks for 7 doses

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.

Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment With Immunosuppressants

The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG.

The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The Myasthenia Gravis Foundation of America task force has recommended that the QMG score be used in prospective studies of therapy for MG. The QMG scoring system consists of 13 items. Each item is graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0-39.

The MGFA PIS is designed to assess the clinical state of MG patients at any time after treatment of MG is initiated. Change in status categories of Improved, Unchanged, Worse, Exacerbation, and Died of MG was to be assessed and recorded at every visit from Visits 3 to 24 (Weeks 1 to 16). Minimal manifestations were to be assessed at these visits.

The MG-ADL is an 8-point questionnaire that focuses on relevant symptoms and functional performance of activities of daily living (ADL) in MG patients. The 8 items of the MG-ADL were derived from symptom-based components of the original 13-item QMG to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 - 24. MG-ADL was to be performed at every study visit. The recall period for MG-ADL was since the preceding study visit (1 or 2 weeks).

The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (physical functioning, role-physical, bodily pain, general health, mental health, role-emotional, social functioning and vitality) as well as psychometrically-based physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group. The lower the score the more disability; the higher the score the less disability. Norm-based scoring involving a linear T-score transformation method was used so that scores for each of the health domain scales and component summary measures have a mean of 50 and a standard deviation of 10 based on the 1998 US general population. Thus, scores above and below 50 are above and below the average, respectively, in the 1998 US general.

Change from Baseline in Forced Vital Capacity

Change from Baseline in Negative Inspiratory Force. NIF is a measurement of respiratory muscle strength and ventilator reserve. NIF is represented by centimeters of water pressure (cmH2O). A normal NIF measurement is negative 60 cmH2O, or as 100% predicted value.

The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.

TEAEs were collected at every visit and follow-up

Placebo

Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses

Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1.

Eculizumab

Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses

Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1.

Eculizumab:

Eculizumab \[600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)\].

Period 1: patients received eculizumab for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received placebo for 16 weeks.

Placebo:

Matching placebo \[IV weekly (4 doses) followed by IV every other week (7 doses)\] Period 1: patients received placebo for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received eculizumab for 16 weeks.

Caucasian

Hispanic

Black

United States

United Kingdom

Region of Enrollment

IIIa

MGFA Classification identifies the subgroup patients with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both.

Myasthenia Gravis Foundation of America (MGFA) classification at Screening

The number of a MG crisis/exacerbation prior to Screening provides pertinent information about disease morbidity and severity.

Number of MG crisis/exacerbation prior to Screening

Prednisone use

No prednisone use

An inclusion criterion was that patients must have failed treatment or failed to achieve significant clinical benefit with at least 2 immunomodulators after 1 year of treatment.

Prednisone use at Screening

Immunosuppression therapy other than prednisone at Screening

Cholinesterase inhibitor use at Screening

The QMG scoring system is considered to be an objective evaluation of therapy for MG and is based on quantitative testing of muscle strength and endurance/fatigue of sentinel muscle groups. The QMG consists of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item) and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 - 39.

Quantitative Myasthenia Gravis (QMG) at Screening

The MG-ADL is a questionnaire that focuses on relevant symptoms and functional performance of activities of daily living in MG patients. The MG-ADL consists of 8 items: ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items). Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 (normal) to 24 (most severe).

Myasthenia Gravis-Activity of Daily Living (MG-ADL)

Small sample size limited ability to detect intercohort differences. Carryover effect from Treatment Period (TP) 1 warrants cautious interpretation of TP 2 data.

Study terminated early; 13 patients received eculizumab or placebo in TP2.

Alexion Pharmaceuticals

eculizumab

eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses

Eculizumab Period 1

Placebo

Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses

Placebo Period 1

Quantitative Myasthenia Gravis (QMG): The Primary Efficacy Endpoint in This Study Was the Percentage of Patients With a 3-point Reduction From Baseline in the QMG Total Score for Disease Severity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)	NCT03759366	Myasthenia Grav... Myasthenia Grav... Myasthenia Grav...	Eculizumab	6 Years - 17 Years	Alexion Pharmaceuticals, Inc.
Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)	NCT01997229	Refractory Gene...	Eculizumab Placebo	18 Years -	Alexion Pharmaceuticals, Inc.
A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)	NCT03759366	Myasthenia Grav... Myasthenia Grav... Myasthenia Grav...	Eculizumab	6 Years - 17 Years	Alexion Pharmaceuticals, Inc.
Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria	NCT00112983	Leukemia	eculizumab	18 Years -	National Cancer Institute (NCI)
Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)	NCT01997229	Refractory Gene...	Eculizumab Placebo	18 Years -	Alexion Pharmaceuticals, Inc.
Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis	NCT00727194	Myasthenia Grav...	eculizumab Placebo	18 Years - 80 Years	Alexion Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for eculizumab

Every month we try and update this database with for eculizumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eculizumab

Every month we try and update this database with for eculizumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eculizumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.