Trial Outcomes & Findings for A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis (NCT NCT01216072)

Last Updated: 2014-02-10

Results Overview

The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1053 participants

Primary outcome timeframe

Baseline, Month 6

Results posted on

2014-02-10

Participant Flow

Patients randomized in a 3:1 ratio to either fingolimod (0.5 mg/day) or MS DMT.

Participant milestones

Participant milestones
Measure	Fingolimod Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Open-Label Core Period ( 6 Months) STARTED	790	263
Open-Label Core Period ( 6 Months) Full Analysis Set	789	263
Open-Label Core Period ( 6 Months) Safety Set	783	245
Open-Label Core Period ( 6 Months) COMPLETED	714	229
Open-Label Core Period ( 6 Months) NOT COMPLETED	76	34
Open-Label Extension Period (3 Months) STARTED	0	195
Open-Label Extension Period (3 Months) Safety Set	0	193
Open-Label Extension Period (3 Months) COMPLETED	0	181
Open-Label Extension Period (3 Months) NOT COMPLETED	0	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Fingolimod Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Open-Label Core Period ( 6 Months) Adverse Event	40	4
Open-Label Core Period ( 6 Months) Abnormal laboratory value(s)	2	0
Open-Label Core Period ( 6 Months) Abnormal test procedure result(s)	3	0
Open-Label Core Period ( 6 Months) Lack of Efficacy	3	4
Open-Label Core Period ( 6 Months) Withdrawal by Subject	12	22
Open-Label Core Period ( 6 Months) Lost to Follow-up	5	0
Open-Label Core Period ( 6 Months) Protocol Deviation	11	4
Open-Label Extension Period (3 Months) Adverse Event	0	10
Open-Label Extension Period (3 Months) Abnormal test procedure results	0	1
Open-Label Extension Period (3 Months) Withdrawal by Subject	0	3

Baseline Characteristics

A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fingolimod n=790 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=263 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Total n=1053 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 9.82 • n=5 Participants	45.1 years STANDARD_DEVIATION 9.82 • n=7 Participants	45.8 years STANDARD_DEVIATION 9.82 • n=5 Participants
Sex: Female, Male Female	601 Participants n=5 Participants	208 Participants n=7 Participants	809 Participants n=5 Participants
Sex: Female, Male Male	189 Participants n=5 Participants	55 Participants n=7 Participants	244 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.

Outcome measures

Outcome measures
Measure	Fingolimod n=714 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=221 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6	22.5 units on a scale Standard Deviation 27.1	3.5 units on a scale Standard Deviation 20.57	—

SECONDARY outcome

Timeframe: 9 months (6 month core + 3 month Extension)

Population: Safety Set included all patients who received at least one dose of study drug.

In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

Outcome measures

Outcome measures
Measure	Fingolimod n=783 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=245 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period n=193 Participants An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death Adverse Events (serious and non-serious)	617 Participants	152 Participants	123 Participants
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death Serious Adverse Events	31 Participants	5 Participants	7 Participants
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death Death	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6

The PRIMUS activity measure is a 15-item assessment of patient-reported ADL. The PRIMUS-Activities total score was calculated by summing the 15 item scores after recoding the responses from 1 - 3 to 0 - 2. Totals scores range from 0 to 30 with higher scores indicating greater activity limitation. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Fingolimod n=734 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=234 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6	-0.6 units on a scale Standard Deviation 4.51	-0.2 units on a scale Standard Deviation 4.97	—

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.

The Fatigue Severity Scale (FSS) is a 9-item assessment scale measuring fatigue and its effects, using a scale from 1 to 7, with higher scores indicating greater fatigue, or greater negative effects of fatigue on daily living. The FSS 9 item total score was calculated by summing the first 9 item scores and dividing by the number of non-missing items. If no more than 20% of the items were missing, the total score was the product of the mean response of the non missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Fingolimod n=789 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=263 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS) Change from Baseline to Month 3 (n=710,232)	-0.3 units on a scale Standard Deviation 1.24	0.0 units on a scale Standard Deviation 1.14	—
Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS) Change from Baseline to Month 6 (n=687,218)	-0.4 units on a scale Standard Deviation 1.24	0.0 units on a scale Standard Deviation 1.13	—

SECONDARY outcome

Timeframe: Baseline, Month 6

The effectiveness scale was scored as follows: 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Fingolimod n=723 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=225 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4	15.5 units on a scale Standard Deviation 27.53	2.8 units on a scale Standard Deviation 19.05	—

SECONDARY outcome

Timeframe: Baseline, Month 6

The Side Effects subscale was scored as follows: question 4 scored as 0(no) or 1(yes); question 5 scored as 1(extremely bothersome) to 5(not at all bothersome); and questions 6 - 8 scored as 1(a great deal) to 5(not at all). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Fingolimod n=708 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=219 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4	22.9 units on a scale Standard Deviation 29.89	3.5 units on a scale Standard Deviation 23.18	—

SECONDARY outcome

Timeframe: Baseline, Month 6

The convenience subscale was scored as follows: questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and question 11 scored as 1(extremely inconvenient) to 7 (extremely convenient). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Fingolimod n=718 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=222 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4	41.8 units on a scale Standard Deviation 22.85	1.5 units on a scale Standard Deviation 18.33	—

SECONDARY outcome

Timeframe: Baseline, Month 6

The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Fingolimod n=789 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=263 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) Physical Function (n=745,226)	1.5 units on a scale Standard Deviation 7.96	0.4 units on a scale Standard Deviation 7.03	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) Role Limitations d/t Physical Health (n=742,226)	2.8 units on a scale Standard Deviation 9.65	1.2 units on a scale Standard Deviation 8.51	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) Bodily Pain (n=742,226)	2.0 units on a scale Standard Deviation 9.7	-0.3 units on a scale Standard Deviation 8.38	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) General Health Perceptions (n=737,224)	0.8 units on a scale Standard Deviation 8.29	-0.3 units on a scale Standard Deviation 7.24	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) Vitality (n=745,227)	2.8 units on a scale Standard Deviation 8.88	0.6 units on a scale Standard Deviation 7.73	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) Social Functioning (n=747,227)	2.6 units on a scale Standard Deviation 10.31	0.8 units on a scale Standard Deviation 10.61	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) Role Limitation d/t Emotional Problems (n=745,226)	1.6 units on a scale Standard Deviation 12.48	-0.6 units on a scale Standard Deviation 11.51	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) General Mental Health (n=745,227)	2.2 units on a scale Standard Deviation 9.62	0.3 units on a scale Standard Deviation 9.37	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) Physical Component Summary Scale (n=724,222)	1.7 units on a scale Standard Deviation 7.41	0.3 units on a scale Standard Deviation 6.48	—
Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) Mental Component Summary Scale (n=724,222)	2.3 units on a scale Standard Deviation 10.03	0.2 units on a scale Standard Deviation 9.62	—

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.

The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory. Each item is scored from 0 to 3. The questions in the BDI-II refer to how the patient has been feeling over the past two weeks specifically. The BDI-II total score was calculated by summing the 21 item scores. Final scores ranged from 0 to 63 where higher scores indicated more severe depression. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change indicates improvement.

Outcome measures

Outcome measures
Measure	Fingolimod n=789 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=263 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II) Change from Baseline to Month 3 (n=748,236)	-3.2 units on a scale Standard Deviation 7.17	-0.8 units on a scale Standard Deviation 6.57	—
Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II) Change from Baseline to Month 6 (n=709,223)	-3.4 units on a scale Standard Deviation 7.64	-0.6 units on a scale Standard Deviation 6.76	—

SECONDARY outcome

Timeframe: Month 3, Month 6

Population: This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with month 3 and month 6 assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.

The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. The assessments were completed at Month 3 and Month 6. A lower score indicates improvement.

Outcome measures

Outcome measures
Measure	Fingolimod n=789 Participants Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Multiple Sclerosis Disease Modifying Treatments (MS DMTs) n=263 Participants Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.	Extension Fingolimod Period An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Physician-reported Clinical Global Impression of Improvement (CGI-I) Month 3 (n=758,242)	3.4 units on a scale Standard Deviation 1.02	3.9 units on a scale Standard Deviation 0.72	—
Physician-reported Clinical Global Impression of Improvement (CGI-I) Month 6 (n=727,228)	3.2 units on a scale Standard Deviation 1.11	3.9 units on a scale Standard Deviation 0.62	—

Adverse Events

Fingolimod

Serious events: 31 serious events

Other events: 316 other events

Deaths: 0 deaths

Standard MS DMT

Serious events: 5 serious events

Other events: 51 other events

Deaths: 0 deaths

Fingolimod Extension Phase

Serious events: 7 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Fingolimod n=783 participants at risk Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.	Standard MS DMT n=245 participants at risk Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.	Fingolimod Extension Phase n=193 participants at risk An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Gastrointestinal disorders Diarrhoea	5.2% 41/783 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	1.6% 4/245 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	1.6% 3/193 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
Gastrointestinal disorders Nausea	6.1% 48/783 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	2.0% 5/245 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	5.7% 11/193 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
General disorders Fatigue	11.5% 90/783 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	5.7% 14/245 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	5.2% 10/193 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
Infections and infestations Nasopharyngitis	5.5% 43/783 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	5.3% 13/245 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	3.6% 7/193 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
Infections and infestations Upper respiratory tract infection	6.5% 51/783 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	3.3% 8/245 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	4.7% 9/193 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
Nervous system disorders Dizziness	6.4% 50/783 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	2.9% 7/245 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	3.6% 7/193 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
Nervous system disorders Headache	12.4% 97/783 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	3.3% 8/245 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	9.8% 19/193 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
Vascular disorders Hypertension	5.5% 43/783 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	1.6% 4/245 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	3.1% 6/193 In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER