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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001290-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany | UNKNOWN |
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This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebif in Relapsing Multiple Sclerosis (RMS) Subjects | Experimental |
| |
| Rebif in Clinically Isolated Syndromes (CIS) Subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebif | Drug | Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Relapse-free RMS Subjects | A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Data was planned to be reported for "Rebif in RMS Subjects" arm. | Month 12 |
| Time to the First Relapse for CIS Subjects | A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the first relapse was defined as the duration from start of the treatment until first relapse. Data was planned to be reported for "Rebif in CIS Subjects" arm. | Baseline up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Treatment Adherence | According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with treatment adherence under different categories (<=50%, >50-75%, >75-90%, >90%) were presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please contact the Merck KGaA Communication Center | Darmstadt | Germany |
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The study was conducted at 7 sites in Romania.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rebif In RMS Subjects | Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. |
| FG001 | Rebif in CIS Subjects | Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rebif In RMS Subjects | Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. |
| BG001 | Rebif in CIS Subjects |
| 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 | Percentage of Relapse-free RMS Subjects | A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Data was planned to be reported for "Rebif in RMS Subjects" arm. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Number | percentage of subjects | Month 12 |
|
Baseline up to 12 months
AE/ADR was planned to be collected for both the arms together.
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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 | Rebif | Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza Like Illness | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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|
| Month 12 |
| Percentage of Subjects With Relapse by Adherence Category | A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with relapses by adherence categories (<=50%, >50-75%, >75-90%, >90%) were presented. Adherence missing are the subjects who withdrew before 12 months and who did not have any relapses before withdrawal. | Month 12 |
| Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Percentage of subjects who prematurely terminated treatment and reasons were presented. | Baseline up to 12 months |
| Percentage of Subjects Free From Clinical Disease Activity | Expanded Disability Status Scale is abbreviated as EDSS. | Baseline up to 12 months |
| Percentage of Subjects Free From Disability Progression | Expanded Disability Status Scale is abbreviated as EDSS. | Baseline up to 12 months |
| Mean Number of Relapses in RMS Subjects | A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. | Month 12 |
| Number of Subjects With Reasons of Missed Injections | Number of subjects with the reasons of missed injections were presented. Aspartate transaminase and alanine transaminase are abbreviated as ALT and AST respectively. Glutamic oxaloacetic transaminase and glutamic pyruvic transaminase are abbreviated as GOT and GPT respectively. | Baseline up to 12 months |
| Overall Evaluation of RebiSmart Use as Assessed by Investigator | Evaluation of RebiSmart was categorized under very easy, quite easy, Neither easy nor difficult, very difficult and missing | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits to clinic by subjects due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Subjects who took consultations with specialists, general practitioners for MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits by healthcare professional to subjects' home were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of times subjects visited emergency room due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days subjects hospitalized due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who paid someone to assist them due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days per week assistant worked for subject due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per week assistant worked for subject due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects whose relatives or friends missed work due to subjects' MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of working days missed by relative or friend due to subjects' MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS). | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any full days from work due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of full days missed from work by subjects were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS). | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any partial days from work due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per day missed from work by subjects were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects accomplished less work due to MS were presented. | Month 12 |
| Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Amount of work done by subjects in spite of multiple sclerosis was presented under different percentages (0-100%) | Month 12 |
| Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. The scores of the MMAS-8 range from 0 to 8. This self-report scale consists of 7 items answered with a yes or no and 1 item with a 5-point Likert scale. A score below 6 indicates low adherence, a score between 6 to < 8 indicates medium adherence and a score of 8 indicates high adherence. | Month 12 |
| Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination | An AE was any untoward medical occurrence in a subject or clinical investigation in a subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to drug treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AE/ADR was planned to be reported for both the arms together. | Baseline up to 12 months |
| Expanded Disability Status Scale (EDSS) Score | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). | Baseline, Month 12 |
| Body Mass Index (BMI) | BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2). | Baseline, Month 12 |
| Protocol Violation |
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| Withdrawal by Subject |
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| Injection site pain and Injection fear |
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| Personal causes |
|
| Personal decision |
|
Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Number of Subjects Living in City or Rural Area | Number of subjects living in city or rural area were presented. | Number | subjects |
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| Geographical Allocation | Number of subjects depending upon the geographical location were presented. | Number | subjects |
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| Nicotine Used Status | Number of subjects with Nicotine used status was categorized under never used, regular user, occasional user and former user. | Number | subjects |
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| Alcohol Consumption | Number | subjects |
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| Primary | Time to the First Relapse for CIS Subjects | A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the first relapse was defined as the duration from start of the treatment until first relapse. Data was planned to be reported for "Rebif in CIS Subjects" arm. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Median | Inter-Quartile Range | months | Baseline up to 12 months |
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| Secondary | Percentage of Subjects With Treatment Adherence | According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with treatment adherence under different categories (<=50%, >50-75%, >75-90%, >90%) were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Number | percentage of subjects | Month 12 |
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| Secondary | Percentage of Subjects With Relapse by Adherence Category | A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with relapses by adherence categories (<=50%, >50-75%, >75-90%, >90%) were presented. Adherence missing are the subjects who withdrew before 12 months and who did not have any relapses before withdrawal. | Full analysis set was used. Here "Number analyzed" signifies those subjects who were evaluable for specified categories. There were no subjects analyzed for certain categories (that is, "Number analyzed"= 0) because no subjects were evaluable for that arm in the specified category. | Posted | Number | percentage of subjects | Month 12 |
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| Secondary | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Percentage of subjects who prematurely terminated treatment and reasons were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Number | percentage of subjects | Baseline up to 12 months |
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| Secondary | Percentage of Subjects Free From Clinical Disease Activity | Expanded Disability Status Scale is abbreviated as EDSS. | Data could not be analyzed for this outcome because this is a composite outcome dependent on subjects free from relapses and EDSS progression, where EDSS progression requires to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated. | Posted | Baseline up to 12 months |
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| Secondary | Percentage of Subjects Free From Disability Progression | Expanded Disability Status Scale is abbreviated as EDSS. | Data could not be analyzed for this outcome because this EDSS progression requires EDSS to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated. | Posted | Baseline up to 12 months |
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| Secondary | Mean Number of Relapses in RMS Subjects | A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | relapses | Month 12 |
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| Secondary | Number of Subjects With Reasons of Missed Injections | Number of subjects with the reasons of missed injections were presented. Aspartate transaminase and alanine transaminase are abbreviated as ALT and AST respectively. Glutamic oxaloacetic transaminase and glutamic pyruvic transaminase are abbreviated as GOT and GPT respectively. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects who missed the injections are evaluable for this outcome measure. | Posted | Number | subjects | Baseline up to 12 months |
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| Secondary | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Evaluation of RebiSmart was categorized under very easy, quite easy, Neither easy nor difficult, very difficult and missing | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Number | subjects | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits to clinic by subjects due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects who visited clinic for MS. | Posted | Mean | Standard Deviation | visits | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Subjects who took consultations with specialists, general practitioners for MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects who visited to doctors for MS. | Posted | Number | subjects | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits by healthcare professional to subjects' home were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | visits | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of times subjects visited emergency room due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | emergency room visits | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days subjects hospitalized due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who paid someone to assist them due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Number | subjects | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days per week assistant worked for subject due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days per week | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per week assistant worked for subject due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours per day | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects whose relatives or friends missed work due to subjects' MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Number | subject | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of working days missed by relative or friend due to subjects' MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS). | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any full days from work due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Number | subjects | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of full days missed from work by subjects were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS). | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any partial days from work due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Number | subjects | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per day missed from work by subjects were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours per day | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects accomplished less work due to MS were presented. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Number | subjects | Month 12 |
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| Secondary | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Amount of work done by subjects in spite of multiple sclerosis was presented under different percentages (0-100%) | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Participants Analyzed" signifies number of subjects evaluable for this outcome measure. | Posted | Number | Subjects | Month 12 |
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| Secondary | Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. The scores of the MMAS-8 range from 0 to 8. This self-report scale consists of 7 items answered with a yes or no and 1 item with a 5-point Likert scale. A score below 6 indicates low adherence, a score between 6 to < 8 indicates medium adherence and a score of 8 indicates high adherence. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Number | subjects | Month 12 |
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| Secondary | Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination | An AE was any untoward medical occurrence in a subject or clinical investigation in a subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to drug treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AE/ADR was planned to be reported for both the arms together. | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Number | subjects | Baseline up to 12 months |
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| Secondary | Expanded Disability Status Scale (EDSS) Score | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 12 |
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| Secondary | Body Mass Index (BMI) | BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2). | Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Kg/m^2 | Baseline, Month 12 |
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| 1 |
| 106 |
| 15 |
| 106 |
| Hepatic Enzyme Increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
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Not provided
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| Adherence >75-90% |
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| Adherence >90% |
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| Missing |
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| Relapse Status Yes, Adherence >50-75% |
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| Relapse Status Yes, Adherence >75-90% |
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| Relapse Status Yes, Adherence >90% |
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| Relapse Status Yes, Adherence Missing |
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| Relapse Status No, Adherence <= 50% |
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| Relapse Status No, Adherence >50-75% |
|
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| Relapse Status No, Adherence >75-90% |
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| Relapse Status No, Adherence >90% |
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| Relapse Status No, Adherence Missing |
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| Relapse Status Missing, Adherence <=50% |
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| Relapse Status Missing, Adherence >50-75% |
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| Relapse Status Missing, Adherence >75-90% |
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| Relapse Status Missing, Adherence >90% |
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| Relapse Status Missing, Adherence Missing |
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| Protocol Non-compliance |
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| Withdrew Consent |
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| Pain at Injection site and fear of Injection |
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| Personal causes |
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| Personal decision |
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| Title | Measurements |
|---|---|
|
| Did not want to have Injection |
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| Pain at Injection site |
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| Flu-like symptoms |
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| Adverse event |
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| Device broken |
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| Device malfunctions |
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| Device not functioning |
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| Difficulty using the device |
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| Elevated ALT and AST |
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| Elevated liver enzymes |
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| Increased GOT and GPT levels |
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| Local erythema and induration |
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| Missed study medication |
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| Forgot the device at home |
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| No access to medication |
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| could not came at the scheduled visit |
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| Patient redrawn intracutaneous |
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| Stop the treatment |
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| Technical problems with Rebismart |
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| Neither easy nor difficult |
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| Quite difficult |
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| Very difficult |
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| Missing |
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| 20% Work Completed |
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| 30% Work Completed |
|
| 40% Work Completed |
|
| 50% Work Completed |
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| 60% Work Completed |
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| 70% Work Completed |
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| 80% Work Completed |
|
| 90% Work Completed |
|
| 100% Work Completed |
|
| High Adherence |
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| Title | Measurements |
|---|---|
|
| AE/ADR Leading to Early Termination |
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