Trial Outcomes & Findings for Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis (NCT NCT01148810)

NCT ID: NCT01148810

Last Updated: 2019-04-25

Results Overview

Preliminary clinical efficacy of BAF312 in patients with Polymyositis and dermatomyositis (PM/DM) using the International Myositis Assessment and Clinical Studies Group (IMACS) core set measures (including manual muscle testing, Physician's Global Activity Assessment (on a horizontal 10 cm visual analogue scale), Patient Global Activity Assessment (on a horizontal 10 cm visual analogue scale), Physical Function (Health Assessment Questionnaire), Muscle-associated Enzymes (CK, LDH, AST, ALT, aldolase) and Extra-Muscular Activity Assessment (Extra-muscular portion of Myositis Disease Activity Assessment Tool).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-04-25

Participant Flow

The study was terminated after 18 patients had been enrolled, of which 14 were eligible for the primary efficacy analysis.

Participant milestones

Measure	BAF312/BAF312 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Overall Study STARTED	8	10
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Measure	BAF312/BAF312 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Overall Study Adverse Event	0	2
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	0	2
Overall Study Protocol Violation	1	0

Baseline Characteristics

Randomized set

Baseline characteristics by cohort

Measure	BAF312/BAF312 n=8 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Total n=18 Participants Total of all reporting groups
Age, Continuous	51.4 Years STANDARD_DEVIATION 6.48 • n=5 Participants • Randomized set	48.1 Years STANDARD_DEVIATION 15.57 • n=7 Participants • Randomized set	49.6 Years STANDARD_DEVIATION 12.18 • n=5 Participants • Randomized set
Sex: Female, Male Female	4 Participants n=5 Participants • Randomized set	7 Participants n=7 Participants • Randomized set	11 Participants n=5 Participants • Randomized set
Sex: Female, Male Male	4 Participants n=5 Participants • Randomized set	3 Participants n=7 Participants • Randomized set	7 Participants n=5 Participants • Randomized set

PRIMARY outcome

Timeframe: 12 weeks

Population: All patients with evaluable (or complete) PD measurement and no major protocol deviations which impact on PD data were included in the PD analysis set.

Preliminary clinical efficacy of BAF312 in patients with Polymyositis and dermatomyositis (PM/DM) using the International Myositis Assessment and Clinical Studies Group (IMACS) core set measures (including manual muscle testing, Physician's Global Activity Assessment (on a horizontal 10 cm visual analogue scale), Patient Global Activity Assessment (on a horizontal 10 cm visual analogue scale), Physical Function (Health Assessment Questionnaire), Muscle-associated Enzymes (CK, LDH, AST, ALT, aldolase) and Extra-Muscular Activity Assessment (Extra-muscular portion of Myositis Disease Activity Assessment Tool).

Outcome measures

Measure	BAF312/BAF312 n=8 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=8 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Number of Participants Who Responded to BAF312	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The Safety set included all patients who received at least one dose of study medication.

Outcome measures

Measure	BAF312/BAF312 n=7 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=8 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Number of Participants With a Change in Steroids Use After BAF312 Administration -Period 2 Steroid reduction	3 Participants	2 Participants
Number of Participants With a Change in Steroids Use After BAF312 Administration -Period 2 Steroid increase1	1 Participants	2 Participants
Number of Participants With a Change in Steroids Use After BAF312 Administration -Period 2 Steroid stable	3 Participants	4 Participants

SECONDARY outcome

Timeframe: baseline to end of trial (day 196)

Population: PK Analysis set in all disease types

Outcome measures

Measure	BAF312/BAF312 n=15 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Mean Plasma Concentrations of BAF312 baseline	0 ng/ml Standard Deviation 0	—
Mean Plasma Concentrations of BAF312 Day 8	29.6 ng/ml Standard Deviation 25.7	—
Mean Plasma Concentrations of BAF312 Day 28	121 ng/ml Standard Deviation 73.1	—
Mean Plasma Concentrations of BAF312 Day 56	160 ng/ml Standard Deviation 62.3	—
Mean Plasma Concentrations of BAF312 Day 84	163 ng/ml Standard Deviation 77.3	—
Mean Plasma Concentrations of BAF312 Day 92	80.0 ng/ml Standard Deviation 83.3	—
Mean Plasma Concentrations of BAF312 Day 112	120 ng/ml Standard Deviation 49.0	—
Mean Plasma Concentrations of BAF312 Day 140	129 ng/ml Standard Deviation 65.5	—
Mean Plasma Concentrations of BAF312 Day 168	125 ng/ml Standard Deviation 61.9	—
Mean Plasma Concentrations of BAF312 Day 196	27.9 ng/ml Standard Deviation 79.2	—

SECONDARY outcome

Timeframe: 12 weeks

Population: The Safety set included all patients who received at least one dose of study medication.

Biomarkers reflecting efficacy in reducing systemic inflammatory components of the disease using serum markers such as C-reactive protein (CRP)

Outcome measures

Measure	BAF312/BAF312 n=7 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=8 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Summary of CRP Levels	4.14 mg/L Standard Deviation 3.870	6.38 mg/L Standard Deviation 8.999

SECONDARY outcome

Timeframe: 12 weeks

Population: All patients with evaluable (or complete) PD measurement and no major protocol deviations which impact on PD data were included in the PD analysis set.

Short Form (36) Health Survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability.

Outcome measures

Measure	BAF312/BAF312 n=4 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=4 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Efficacy in Modifying Health-related Quality of Life Measured by SF-36 Physical component score	36.469 score on a scale Standard Deviation 7.5520	30.406 score on a scale Standard Deviation 14.5402
Efficacy in Modifying Health-related Quality of Life Measured by SF-36 Mental component score	44.449 score on a scale Standard Deviation 7.2194	49.063 score on a scale Standard Deviation 12.9628

SECONDARY outcome

Timeframe: Week 12

Population: PD set in all disease types

Myositis Disease Activity Scores. This is a combined tool that captures the physician's assessment of disease activity of various organ systems via the MYOSITIS INTENTION TO TREAT ACTIVITY INDEX (MITAX) and via the MYOSITIS DISEASE ACTIVITY ASSESSMENT VISUAL ANALOGUE SCALES (MYOACT) It rates the physician's overall assessment of the ongoing current disease activity for various systems by drawing a vertical mark on the 10-cm line for each system according to the following scale: left end of line = no evidence of disease activity, midpoint of line = moderate disease activity, and right end of line = extreme or maximum disease activity.

Outcome measures

Measure	BAF312/BAF312 n=8 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Myositis Disease (MD) Activity Scores Extramuscular global assessment	1.51 cm Standard Deviation 1.171	2.27 cm Standard Deviation 1.607
Myositis Disease (MD) Activity Scores Cutaneous disease activity	1.11 cm Standard Deviation 0.997	1.31 cm Standard Deviation 1.999

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: PD set in all disease types

Physician's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.

Outcome measures

Measure	BAF312/BAF312 n=8 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Physician Global Activity Assessment Baseline	4.88 cm Standard Deviation 0.947	3.93 cm Standard Deviation 1.557
Physician Global Activity Assessment Week 12	3.04 cm Standard Deviation 1.816	4.91 cm Standard Deviation 2.601

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: PD set in all disease types

Patient's overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.

Outcome measures

Measure	BAF312/BAF312 n=8 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Patient Global Activity Assessment Baseline	4.36 cm Standard Deviation 1.986	4.75 cm Standard Deviation 2.435
Patient Global Activity Assessment Week 12	4.50 cm Standard Deviation 1.557	5.44 cm Standard Deviation 2.421

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: PD set in all disease types

Manual Muscle Testing - 8 (MMT-8): Assessment of designated muscles manually by scoring each muscle from 0 to 10 where 0 is no strength and 10 is maximum strength. MMT- 8 includes 7 bilateral muscles (potential score 0-70 x 2) and one unilateral (axial) muscle (0-10 x1) so the total score ranges from 0 to 150 (maximum) where higher score indicates more strength.

Outcome measures

Measure	BAF312/BAF312 n=8 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Manual Muscle Testing (MMT) - 8 Score Baseline	106.8 scores on a scale Standard Deviation 12.56	106.6 scores on a scale Standard Deviation 19.70
Manual Muscle Testing (MMT) - 8 Score Week 12	115.0 scores on a scale Standard Deviation 10.31	100.7 scores on a scale Standard Deviation 23.75

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: PD set in all disease types

Health Assessment Questionnaire (HAQ): This questionnaire is a patient reported outcome (PRO) which is self-administered by the patient. It is used to assess disability and comprises various categories related to usual daily activities. The patients report the amount of difficulty they have in performing some of these activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). The total score is derived from these sub-scores and ranges from 0 to 3 where higher HAQ indicates more disability.

Outcome measures

Measure	BAF312/BAF312 n=8 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Health Assessment Questionnaire Baseline	1.2969 Score on a scale Standard Deviation 0.53426	1.2031 Score on a scale Standard Deviation 0.90863
Health Assessment Questionnaire Week 12	1.2143 Score on a scale Standard Deviation 0.41278	1.3929 Score on a scale Standard Deviation 0.86129

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: PD set in all disease types

Outcome measures

Measure	BAF312/BAF312 n=8 Participants 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 Participants 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Serum Levels of Muscle Enzymes Creatine Kinase - Baseline	204.0 U/L Standard Deviation 237.37	872.5 U/L Standard Deviation 1256.60
Serum Levels of Muscle Enzymes Creatine Kinase - Week 12	153.7 U/L Standard Deviation 128.62	858.1 U/L Standard Deviation 1499.12

Adverse Events

BAF312/BAF312

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo/BAF312

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	BAF312/BAF312 n=16 participants at risk 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 participants at risk 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Hepatobiliary disorders Cholelithiasis	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Infections and infestations Peritonitis	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.

Other adverse events

Measure	BAF312/BAF312 n=16 participants at risk 2 tablets each of BAF312 5mg for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2	Placebo/BAF312 n=10 participants at risk 2 tablets of Placebo for oral administration in period 1 and 2 tablets each of BAF312 5mg in period 2
Cardiac disorders Palpitations	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Eye disorders Cataract	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Eye disorders Conjunctivitis	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Eye disorders Macular oedema	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Eye disorders Periorbital oedema	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Eye disorders Vision blurred	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Eye disorders Visual acuity reduced	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Abdominal pain upper	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Dental caries	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Diarrhoea	12.5% 2/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Dysphagia	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Frequent bowel movements	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Haemorrhoids	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Nausea	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Gastrointestinal disorders Salivary hypersecretion	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
General disorders Oedema peripheral	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
General disorders Pyrexia	12.5% 2/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Infections and infestations Bronchitis	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Infections and infestations Oral herpes	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Infections and infestations Tinea versicolour	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Injury, poisoning and procedural complications Spinal compression fracture	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 2/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Nervous system disorders Dizziness	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Nervous system disorders Dysgeusia	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Nervous system disorders Headache	25.0% 4/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	20.0% 2/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Nervous system disorders Sciatica	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Nervous system disorders Tremor	12.5% 2/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	40.0% 4/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Respiratory, thoracic and mediastinal disorders Productive cough	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Skin and subcutaneous tissue disorders Mechanical urticaria	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Skin and subcutaneous tissue disorders Rash	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Skin and subcutaneous tissue disorders Rosacea	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Skin and subcutaneous tissue disorders Skin mass	6.2% 1/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Vascular disorders Haematoma	0.00% 0/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	10.0% 1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.
Vascular disorders Hypertension	12.5% 2/16 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.	0.00% 0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2 years. This was a randomized, double-blind, placebo-controlled trial followed by an open label extension period where all patients received BAF312.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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 (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER