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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-000601-32 | EudraCT Number |
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The main purpose of this study was to assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing multiple sclerosis (RMS)
This was a 24-month, open-label, multicenter, interventional, single-arm study to collect efficacy and, safety of oral fingolimod 0.5 mg/day in approximately 100 relapsing multiple sclerosis (RMS) participants in China.
The study consisted of three Phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod | Experimental | Fingolimod 0.5 mg capsule taken orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod 0.5mg | Drug | Subjects received fingolimod 0.5mg capsule QD up to month 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Annualized Relapse Rate (ARR) in Adult Group | A confirmed relapse is any relapse that is accompanied by an increase of at least 0.5 on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS) as confirmed by the treating physician. The adjusted annualized relapse rate (ARR) was estimated by a negative binomial regression model with log-link function, the cumulative number of confirmed MS relapses per subject as the response variable, number of relapses in the previous two years before enrollment and baseline EDSS as continuous covariates. Natural log of time on study in years was used as the offset variable to account for the varying lengths of subjects' time in the study. The adjusted ARR (i.e.model-based estimate adjusted for covariates) and the corresponding 95% confidence interval were obtained. As per SAP this analysis was only performed for the Adult group. Descriptive data is presented in subsequent OMs. | Baseline to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject after providing written informed consent for participation in the study. For reporting purposes, the main focus was on treatment emergent adverse event (TEAE), defined as any AE which started on or after the day of first dose of study medication or events present prior to the start of treatment but increased in severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Beijing | Beijing Municipality | 100000 | China | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Pediatric Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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There were up to 30 days of screening period (day -30 to -1) before first treatment (day 1).
Participants were enrolled at 13 sites in China
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| ID | Title | Description |
|---|---|---|
| FG000 | Fingolimod (< 18 Years) | Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old |
| FG001 | Fingolimod > 18 Years | Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2023 | Aug 8, 2025 |
Not provided
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| From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months |
| Annualized Rate of the Number of New or Newly Enlarged T2 Lesions | Obtained from fitting a negative binomial regression model with log-link function, the total number of new or newly enlarged T2 lesions during the treatment period (per participant) as the response variable. The model included baseline age and volume of T2 lesions at baseline as continuous covariates. Natural log of time from screening scan in years was used as the offset. Baseline is defined as the last non-missing assessment obtained prior to the first administration of study drug. As per SAP this analysis was only performed for the Adult group. | Baseline to end of treatment (up to Month 24) |
| Change From Baseline in Number of New or Newly Enlarged T2 Lesions | Number of new/newly enlarged T2 lesions since baseline as measured by MRI | Baseline up to Month 24 |
| Change From Baseline in T2 Lesion Volume | T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value | Baseline up to Month 24 |
| Number of Gd-enhancing T1 Lesions Per Scan in Adult Group | Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per patient) as the response variable. The model included baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans was used as the offset. MRI scans were performed at baseline, month 12 and month 24 and End of treatment for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. As per SAP this analysis was only performed for the Adult group. | Baseline up to Month 24 |
| Number of Gd-enhancing T1 Lesions | Number of Gd-enhancing T1 lesions as measured by MRI | Baseline up to Month 24 |
| Change From Baseline in Gd-enhancing T1 Lesion Volume | Gd-enhancing T1 lesion volume as measured by MRI and calculated as post-baseline value - baseline value | Baseline up to Month 24 |
| Number of T1 Hypo-intense Lesions | Number of T1 hypo-intense lesions as measured by MRI | Baseline up to Month 24 |
| Change From Baseline in T1 Hypo-intense Lesion Volume | T1 hypo-intense lesions as measured by MRI and calculated as post-baseline value - baseline value | Baseline up to Month 24 |
| Guangzhou |
| Guangdong |
| 510623 |
| China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510630 | China |
| Novartis Investigative Site | Zhengzhou | Henan | 450052 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430030 | China |
| Novartis Investigative Site | Suzhou | Jiangsu | 215004 | China |
| Novartis Investigative Site | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Wenzhou | Zhejiang | 325000 | China |
| Novartis Investigative Site | Beijing | 065001 | China |
| Novartis Investigative Site | Beijing | 100028 | China |
| Novartis Investigative Site | Guangzhou | 510260 | China |
| Novartis Investigative Site | Shanghai | 200040 | China |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fingolimod (< 18 Years) | Fingolimod 0.5 mg capsule taken orally once daily in participants under 18 years old |
| BG001 | Fingolimod > 18 Years | Fingolimod 0.5 mg capsule taken orally once daily in participants 18 years old or over |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Age categorical | Count of Participants | Participants |
| ||||||||||||||||
| Number of relapses in the last 12 months prior to screening | Mean | Standard Deviation | relapses/year |
| |||||||||||||||
| Number of relapses in 12 to 24 months prior to screening | Mean | Standard Deviation | relapses/year |
|
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Post-Hoc | Participant Based Annualized Relapse Rate (ARR) | A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Participant-based ARR was calculated by taking the total number of relapses observed for a participant divided by the total number of days in study of that participant and multiplied by 365.25. | Full Analysis Set (FAS): all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Mean | Standard Deviation | relapses per participant-year | Baseline to Month 24 |
|
|
| |||||||||||||||||||||||||||||||||||
| Post-Hoc | Time Based Annualized Relapse Rate (ARR) | A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Time-based ARR was calculated by taking the total number of relapses observed for all subjects within an age group divided by the total number of days in study of all subjects within the group and multiplied by 365.25 days. | Full Analysis Set (FAS): all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Number | relapses per participant-year | Baseline to Month 24 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Adjusted Annualized Relapse Rate (ARR) in Adult Group | A confirmed relapse is any relapse that is accompanied by an increase of at least 0.5 on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS) as confirmed by the treating physician. The adjusted annualized relapse rate (ARR) was estimated by a negative binomial regression model with log-link function, the cumulative number of confirmed MS relapses per subject as the response variable, number of relapses in the previous two years before enrollment and baseline EDSS as continuous covariates. Natural log of time on study in years was used as the offset variable to account for the varying lengths of subjects' time in the study. The adjusted ARR (i.e.model-based estimate adjusted for covariates) and the corresponding 95% confidence interval were obtained. As per SAP this analysis was only performed for the Adult group. Descriptive data is presented in subsequent OMs. | Adult participants in the Full Analysis Set (FAS). FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | relapses per participant-year | Baseline to Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject after providing written informed consent for participation in the study. For reporting purposes, the main focus was on treatment emergent adverse event (TEAE), defined as any AE which started on or after the day of first dose of study medication or events present prior to the start of treatment but increased in severity. | Posted | Count of Participants | Participants | From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of the Number of New or Newly Enlarged T2 Lesions | Obtained from fitting a negative binomial regression model with log-link function, the total number of new or newly enlarged T2 lesions during the treatment period (per participant) as the response variable. The model included baseline age and volume of T2 lesions at baseline as continuous covariates. Natural log of time from screening scan in years was used as the offset. Baseline is defined as the last non-missing assessment obtained prior to the first administration of study drug. As per SAP this analysis was only performed for the Adult group. | Adult participants in the Full Analysis Set (FAS) with available data for the outcome measure.. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Lesions per participant-year | Baseline to end of treatment (up to Month 24) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Number of New or Newly Enlarged T2 Lesions | Number of new/newly enlarged T2 lesions since baseline as measured by MRI | Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Mean | Standard Deviation | new / newly enlarged T2 lesions | Baseline up to Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in T2 Lesion Volume | T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value | Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Median | Full Range | milliliters | Baseline up to Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Gd-enhancing T1 Lesions Per Scan in Adult Group | Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per patient) as the response variable. The model included baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans was used as the offset. MRI scans were performed at baseline, month 12 and month 24 and End of treatment for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. As per SAP this analysis was only performed for the Adult group. | Adult participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Lesions per participant per scan | Baseline up to Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Gd-enhancing T1 Lesions | Number of Gd-enhancing T1 lesions as measured by MRI | Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Mean | Standard Deviation | T1 lesions | Baseline up to Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Gd-enhancing T1 Lesion Volume | Gd-enhancing T1 lesion volume as measured by MRI and calculated as post-baseline value - baseline value | Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Median | Full Range | microliters | Baseline up to Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of T1 Hypo-intense Lesions | Number of T1 hypo-intense lesions as measured by MRI | Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Mean | Standard Deviation | T1 hypo-intense lesions | Baseline up to Month 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in T1 Hypo-intense Lesion Volume | T1 hypo-intense lesions as measured by MRI and calculated as post-baseline value - baseline value | Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Posted | Median | Full Range | microliters | Baseline up to Month 24 |
|
|
Adverse events were reported from first dose of study treatment to 60 days after last study dose up to approximately 26 months
Not provided
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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 | Less Than 18 Years | Less than 18 years | 0 | 11 | 3 | 11 | 11 | 11 |
| EG001 | Greater Than or Equal to 18 Years | Greater than or equal to 18 years | 0 | 87 | 12 | 87 | 85 | 87 |
| EG002 | Overall | Overall | 0 | 98 | 15 | 98 | 96 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iridocyclitis | Eye disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Acute disseminated encephalomyelitis | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Abortion complete | Pregnancy, puerperium and perinatal conditions | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglobulinaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Refraction disorder | Eye disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Electrocardiogram PR shortened | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Electrocardiogram ST segment abnormal | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Electrocardiogram high voltage | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Lymphocyte percentage decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Neutrophil percentage increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary sediment present | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Urine abnormality | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nail bed inflammation | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2025 | Aug 8, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Adolescents 12-17 years |
|
| Adults 18-64 years |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
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