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| Name | Class |
|---|---|
| Merck Serono S.A.S, France | INDUSTRY |
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This study is planned to evaluate emotional disorders during treatment by interferon (IFN) beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label exploratory study with no change of therapeutic behavior but with standardized neuropsychologic follow-up.
This study is planned to evaluate emotional disorders during treatment by IFN beta in RRMS subjects. This is an open-label, prospective, interventional, multicentric study with no change of therapeutic behavior but with standardized neuropsychologic follow-up. Subjects will undergo 13 evaluations (categorical and dimensional evaluations), 3 evaluations will be performed before the treatment (Baseline, Day 7 and 15) and 10 evaluations after the treatment (Month 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1a | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) | Baseline and Month 12 |
| Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) | Baseline and Month 18 |
| Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) | Baseline and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Brochet, MD, Prof. | Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17457294 | Background | Radat F, Lafittau M, Ouallet JC, Brochet B, Jouvent R. [Validation of EHD self questionnaire in multiple sclerosis]. Encephale. 2007 Jan-Feb;33(1):49-57. doi: 10.1016/s0013-7006(07)91558-4. French. | |
| 10467380 | Background | Sharrack B, Hughes RA. The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler. 1999 Aug;5(4):223-33. doi: 10.1177/135245859900500406. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interferon-beta | Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interferon-beta | Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Out of a total of 79 participants, data for baseline measure (age) was available for 70 participants with at least one interferon-beta intake and with at least one evaluation of the primary criterion. |
| 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 | Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) | Intent-to-treat (ITT) population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Month 12 |
|
Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
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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 | Interferon-beta | Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 |
| Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983) | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 |
| Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977) | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 |
| Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996) | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 |
| Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999) | Baseline, Months 1, 2, 3, 6, 12, and 24 |
| Background | Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press |
| Background | Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-401. |
| Background | Spielberger CD. Manual for the State-Anger Expression Inventory. Odessa, FL: Psychological Assessment Resources; 1996 |
| Lack of Efficacy |
|
| Participant wrongly included in trial |
|
| Randomized, not treated |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Out of a total of 79 participants, data for baseline measure (gender) was available for 70 participants with at least one interferon-beta intake and with at least one evaluation of the primary criterion. | Count of Participants | Participants |
|
| Interferon-beta |
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years. |
|
|
| Primary | Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) | ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Month 18 |
|
|
|
| Primary | Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) | ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Month 24 |
|
|
|
| Secondary | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007) | ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 |
|
|
|
| Secondary | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983) | ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 |
|
|
|
| Secondary | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977) | ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 |
|
|
|
| Secondary | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996) | ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 |
|
|
|
| Secondary | Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999) | ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 1, 2, 3, 6, 12, and 24 |
|
|
|
| 9 |
| 76 |
| 62 |
| 76 |
| Sudden Hearing Loss | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Drug Dependence | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Aggressivity | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Neck Injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Nystagmus | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Restless Legs Syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Haematoma | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection Site Reaction | General disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Emotional Distress | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Panic Attack | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Rhinolaryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary Tract Infection ba | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tendon Disorder | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Faecal Incontinence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Procedural Headache | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Menlere's Disease | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Cytolytic Hepatitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Gamma-glutamyltransferase | Investigations | MedDRA | Non-systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA | Non-systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Non-systematic Assessment |
|
| Raynaud's Phenomenon | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| Title | Measurements |
|---|---|
|
| Change at Month 3 (n= 64) |
|
| Change at Month 4 (n= 59) |
|
| Change at Month 5 (n= 58) |
|
| Change at Month 6 (n= 56) |
|
| Change at Month 9 (n= 58) |
|
| Change at Month 12 (n= 57) |
|
| Change at Month 18 (n= 61) |
|
| Change at Month 24 (n= 63) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 3 (n= 64) |
|
| Change at Month 4 (n= 59) |
|
| Change at Month 5 (n= 58) |
|
| Change at Month 6 (n= 55) |
|
| Change at Month 9 (n= 58) |
|
| Change at Month 12 (n= 57) |
|
| Change at Month 18 (n= 61) |
|
| Change at Month 24 (n= 63) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 3 (n= 64) |
|
| Change at Month 4 (n= 58) |
|
| Change at Month 5 (n= 58) |
|
| Change at Month 6 (n= 56) |
|
| Change at Month 9 (n= 58) |
|
| Change at Month 12 (n= 57) |
|
| Change at Month 18 (n= 61) |
|
| Change at Month 24 (n= 63) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 3 (n= 64) |
|
| Change at Month 4 (n= 59) |
|
| Change at Month 5 (n= 58) |
|
| Change at Month 6 (n= 56) |
|
| Change at Month 9 (n= 58) |
|
| Change at Month 12 (n= 57) |
|
| Change at Month 18 (n= 61) |
|
| Change at Month 24 (n= 63) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 3 (n= 56) |
|
| Change at Month 6 (n= 50) |
|
| Change at Month 12 (n= 49) |
|
| Change at Month 24 (n= 56) |
|