Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following ischemic stroke.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGb761® | Experimental | EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day). The test treatment consists of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch. |
|
| Placebo | Placebo Comparator | 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day). The placebo consists of 6 tablets/day. 2 tablets taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGb761 | Drug | EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. | The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at the end of the study (Day 168) are reported. | Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. | The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at each follow-up visit (not including end of study) are reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine in Hradec Kralove | Hradec Králové | 500 02 | Czechia | |||
| General Faculty Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
The inclusion (baseline) visit on Day 0 was to take place within 3-8 days following an ischaemic stroke.
This was a multicentre, international, randomised, double-blind, placebo-controlled study in which 204 subjects were enrolled in 8 centres, distributed in 4 countries: Romania, Poland, Czech Republic and Russian Federation, from 20 February 2003 to 25 February 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EGb761® | Subjects received EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day). The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch. |
| FG001 | Placebo | Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day). The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EGb761® | Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day). The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. | The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at the end of the study (Day 168) are reported. | This analysis was performed on the Intention-To-Treat (ITT) population which includes all subjects having at least one treatment dose. | Posted | Number | percentage of participants | Day 168 |
|
Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EGb761® | Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day). The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischaemic stroke | Nervous system disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome in 1 subject |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen | clinical.trials@ipsen.com |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C063170 | Ginkgo biloba extract |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months. |
|
| Acetylsalicylic acid | Drug | Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months. |
|
| Up to Day 84 |
| Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | The degree of disability and dependence in daily activities was assessed using the modified Rankin scale.The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability,3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The distribution of subjects according to disability severity scores was assessed and the percentage of subjects at each point on the modified Rankin scale are reported for each time point. | Up to Day 168 |
| Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | The SCAG scale was to be used to evaluate the psychopathological state of the subject. It is composed of 18 symptom areas and an overall global assessment, all rated on a 7-point format from 1=not present to 7=severe. The total score range is from 19 to 133 (best to worst), with a negative mean change from baseline indicating an improvement in symptoms. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported. | Up to Day 168 |
| Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | The performance in activities of daily living was assessed by using the Barthel scale. The Barthel scale is an ordinal scale which measures 10 performance items describing activities of daily living. Each item is rated with a given number of points from 0 indicating total dependence up to a maximum of 10 or 15 (depending on performance item) indicating complete independence. The total score range is from 0 to 100 (worst to best), with a positive mean change indicating an improvement in independence. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported. | Up to Day 168 |
| Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | The MMS test was used to evaluate the cognitive function of the subject. It includes tests of orientation, attention, memory, language and visual spatial skills, which are rated with a given number of points assigned to each level or ranking. The lower the score, the more important the mental deficit. The total score range is from 0 to 30 (worst to best), with a positive mean change indicating an improvement (i.e. less mental deficit). Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported. | Up to Day 168 |
| Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168. | The NIHSS was to be used to objectively quantify the impairment caused by the stroke.The NIHSS is composed of 11 items, each of which score a specific ability between 0 (normal function) and 4 (high level of impairment).The minimum total score is 0 and maximum is 42. Only 8 of the NIHSS subscores were calculated for this study. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. Mean NIHSS subscores for questions 1a (level of consciousness),1b (asking patient the month and their age), and 1c (asking to open and close eyes) were analysed using descriptive quantitative statistics at each visit and the mean change from baseline at each time point is reported. The range for the subscore for items 1a is 0 - 3, for 1b is 0 - 2 and for 1c is 0 - 2 (best to worst), with a negative mean change from baseline indicating an improvement. | Up to Day 168 |
| Prague |
| 120 00 |
| Czechia |
| Department and Clinic of Neurology of the Old Age | Katowice | 40 752 | Poland |
| CMUJ Krakov | Krakow | 31503 | Poland |
| Postgraduate Medical Teaching Center | Warsaw | 00 416 | Poland |
| Institul de Boli Cerebro Vascular | Bucharest | 75622 | Romania |
| Spitalul Universitar de Urgenta | Bucharest | Sector 5 | Romania |
| Russian State Medical University - Neurology and Neurosurgery Clinic | Moscow | 117415 | Russia |
| Russian State Medical University - Dept Fundamental Neurology & Neurosurgery | Moscow | 129327 | Russia |
| Ural State Medical Academy | Yekaterinburg | 620102 | Russia |
| Withdrawal by Subject |
|
| Death |
|
| Abnormal aPPT Levels |
|
| BG001 |
| Placebo |
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day). The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
| OG001 | Placebo | Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day). The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch. |
|
|
|
| Secondary | Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. | The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at each follow-up visit (not including end of study) are reported. | This analysis was performed on the ITT population which includes all subjects having at least one treatment dose. | Posted | Number | percentage of participants | Up to Day 84 |
|
|
|
|
| Secondary | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | The degree of disability and dependence in daily activities was assessed using the modified Rankin scale.The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability,3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The distribution of subjects according to disability severity scores was assessed and the percentage of subjects at each point on the modified Rankin scale are reported for each time point. | This analysis was performed on the ITT population which includes all subjects having at least one treatment dose. | Posted | Number | percentage of participants | Up to Day 168 |
|
|
|
| Secondary | Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | The SCAG scale was to be used to evaluate the psychopathological state of the subject. It is composed of 18 symptom areas and an overall global assessment, all rated on a 7-point format from 1=not present to 7=severe. The total score range is from 19 to 133 (best to worst), with a negative mean change from baseline indicating an improvement in symptoms. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported. | This analysis was performed on the ITT population which includes all subjects having at least one treatment dose. | Posted | Mean | Standard Deviation | units on a scale | Up to Day 168 |
|
|
|
|
| Secondary | Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | The performance in activities of daily living was assessed by using the Barthel scale. The Barthel scale is an ordinal scale which measures 10 performance items describing activities of daily living. Each item is rated with a given number of points from 0 indicating total dependence up to a maximum of 10 or 15 (depending on performance item) indicating complete independence. The total score range is from 0 to 100 (worst to best), with a positive mean change indicating an improvement in independence. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported. | This analysis was performed on the ITT population which includes all subjects having at least one treatment dose. | Posted | Mean | Standard Deviation | units on a scale | Up to Day 168 |
|
|
|
|
| Secondary | Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | The MMS test was used to evaluate the cognitive function of the subject. It includes tests of orientation, attention, memory, language and visual spatial skills, which are rated with a given number of points assigned to each level or ranking. The lower the score, the more important the mental deficit. The total score range is from 0 to 30 (worst to best), with a positive mean change indicating an improvement (i.e. less mental deficit). Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported. | This analysis was performed on the ITT population which includes all subjects having at least one treatment dose. | Posted | Mean | Standard Deviation | units on a scale | Up to Day 168 |
|
|
|
|
| Secondary | Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168. | The NIHSS was to be used to objectively quantify the impairment caused by the stroke.The NIHSS is composed of 11 items, each of which score a specific ability between 0 (normal function) and 4 (high level of impairment).The minimum total score is 0 and maximum is 42. Only 8 of the NIHSS subscores were calculated for this study. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. Mean NIHSS subscores for questions 1a (level of consciousness),1b (asking patient the month and their age), and 1c (asking to open and close eyes) were analysed using descriptive quantitative statistics at each visit and the mean change from baseline at each time point is reported. The range for the subscore for items 1a is 0 - 3, for 1b is 0 - 2 and for 1c is 0 - 2 (best to worst), with a negative mean change from baseline indicating an improvement. | This analysis was performed on the ITT population which includes all subjects having at least one treatment dose. | Posted | Mean | Standard Deviation | units on a scale | Up to Day 168 |
|
|
|
| 5 |
| 101 |
| 12 |
| 101 |
| 16 |
| 101 |
| EG001 | Placebo | Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day). The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch. | 3 | 100 | 7 | 100 | 17 | 100 |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Cardiac failure | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Cellulitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Cystitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA (9.1) | Systematic Assessment | AE had fatal outcome |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (9.1) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (9.1) | Systematic Assessment |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
|
The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test. |
| Cochran-Mantel-Haenszel |
| 0.3 |
| Odds Ratio (OR) |
| 0.74 |
| 2-Sided |
| 95 |
| 0.42 |
| 1.3 |
The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test. |
| Other |
Comparison of treatment effect at Day 84 |
| Day 0: No significant disability |
|
|
| Day 0: Slight disability |
|
|
| Day 0: Moderate disability |
|
|
| Day 0: Moderately severe disability |
|
|
| Day 0: Severe disability |
|
|
| Day 28: No symptoms at all |
|
|
| Day 28: No significant disability |
|
|
| Day 28: Slight disability |
|
|
| Day 28: Moderate disability |
|
|
| Day 28: Moderately severe disability |
|
|
| Day 28: Severe disability |
|
|
| Day 84: No symptoms at all |
|
|
| Day 84: No significant disability |
|
|
| Day 84: Slight disability |
|
|
| Day 84: Moderate disability |
|
|
| Day 84: Moderately severe disability |
|
|
| Day 84: Severe disability |
|
|
| Day 168: No symptoms at all |
|
|
| Day 168: No significant disability |
|
|
| Day 168: Slight disability |
|
|
| Day 168: Moderate disability |
|
|
| Day 168: Moderately severe disability |
|
|
| Day 168: Severe disability |
|
|
| Day 84 |
|
|
| Day 168 |
|
|
| ANCOVA |
| 0.590 |
Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates. |
| Other |
| Comparison of treatment effect at Day 168 | ANCOVA | 0.814 | Other | Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates. |
| Day 84 |
|
|
| Day 168 |
|
|
| ANCOVA |
| 0.441 |
Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates. |
| Other |
| Comparison of treatment effect at Day 168 | ANCOVA | 0.645 | Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates. | Other |
| Day 84 |
|
|
| Day 168 |
|
|
| ANCOVA |
| 0.338 |
Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates. |
| Other |
| Comparison of treatment effect at Day 168 | ANCOVA | 0.828 | Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates | Other |
| Day 84 |
|
|
| Day 168 |
|
|