Trial Outcomes & Findings for Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression (NCT NCT01436643)

NCT ID: NCT01436643

Last Updated: 2014-09-25

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 54 participants
• Primary outcome timeframe: 21 weeks
• Results posted on: 2014-09-25

Participant Flow

The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant

Participant milestones

Measure	Fluoxetine and Fingolimod Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg	Venlafaxine and Fingolimod Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg	Citalopram and Fingolimod Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg	Pre-treatment With Fingolimod During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.
2-week Pre-treatment STARTED	0	0	0	54
2-week Pre-treatment COMPLETED	0	0	0	44
2-week Pre-treatment NOT COMPLETED	0	0	0	10
Core Phase (16 Weeks) STARTED	17	15	20	0
Core Phase (16 Weeks) COMPLETED	16	11	17	0
Core Phase (16 Weeks) NOT COMPLETED	1	4	3	0

Reasons for withdrawal

Measure	Fluoxetine and Fingolimod Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg	Venlafaxine and Fingolimod Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg	Citalopram and Fingolimod Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg	Pre-treatment With Fingolimod During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.
2-week Pre-treatment Abnormal test result	0	0	0	1
2-week Pre-treatment Adverse Event	0	0	0	5
2-week Pre-treatment Protocol Violation	0	0	0	4
Core Phase (16 Weeks) Adverse Event	0	3	1	0
Core Phase (16 Weeks) Abnormal Test result	0	0	1	0
Core Phase (16 Weeks) Protocol Violation	1	1	1	0

Baseline Characteristics

Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression

Baseline characteristics by cohort

Measure	Fluoxetine and Fingolimod n=17 Participants Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg	Venlafaxine and Fingolimod n=15 Participants Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg	Citalopram and Fingolimod n=20 Participants Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg	Total n=52 Participants Total of all reporting groups
Age, Continuous	44.2 Years STANDARD_DEVIATION 9.22 • n=5 Participants	40.0 Years STANDARD_DEVIATION 9.28 • n=7 Participants	41.2 Years STANDARD_DEVIATION 10.22 • n=5 Participants	41.8 Years STANDARD_DEVIATION 9.87 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants

PRIMARY outcome

Timeframe: 21 weeks

Population: The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant

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

See Safety Section.

Outcome measures

Measure	Fluoxetine and Fingolimod n=17 Participants Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg	Venlafaxine and Fingolimod n=15 Participants Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg	Citalopram and Fingolimod n=20 Participants Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg	Fingolimod n=54 Participants 2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death Any Adverse Event	11 Participants	12 Participants	12 Participants	15 Participants
Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death Death	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death Serious Adverse Event	0 Participants	1 Participants	1 Participants	1 Participants

Adverse Events

Fingolimod

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Venlafaxine and Fingolimod

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Citalopram and Fingolimod

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Fluoxetine and Fingolimod

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fingolimod n=54 participants at risk 2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.	Venlafaxine and Fingolimod n=15 participants at risk Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg	Citalopram and Fingolimod n=20 participants at risk Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg	Fluoxetine and Fingolimod n=17 participants at risk Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
Nervous system disorders CEREBRAL HAEMORRHAGE	1.9% 1/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.

Other adverse events

Measure	Fingolimod n=54 participants at risk 2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.	Venlafaxine and Fingolimod n=15 participants at risk Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg	Citalopram and Fingolimod n=20 participants at risk Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg	Fluoxetine and Fingolimod n=17 participants at risk Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
Blood and lymphatic system disorders LYMPHOPENIA	11.1% 6/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Cardiac disorders TACHYCARDIA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Eye disorders ASTHENOPIA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Gastrointestinal disorders CONSTIPATION	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Gastrointestinal disorders DIARRHOEA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Gastrointestinal disorders DRY MOUTH	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Gastrointestinal disorders NAUSEA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	20.0% 3/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	20.0% 4/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	23.5% 4/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Gastrointestinal disorders TOOTHACHE	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
General disorders FATIGUE	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	11.8% 2/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
General disorders FEELING HOT	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
General disorders OEDEMA PERIPHERAL	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
General disorders PAIN	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
General disorders THIRST	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Infections and infestations BRONCHITIS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Infections and infestations GASTROINTESTINAL INFECTION	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Infections and infestations INFLUENZA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Infections and infestations NASOPHARYNGITIS	3.7% 2/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	11.8% 2/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Infections and infestations RHINITIS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Infections and infestations TONSILLITIS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.9% 1/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Injury, poisoning and procedural complications FALL	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Investigations ELECTROCARDIOGRAM ABNORMAL	1.9% 1/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Investigations LABORATORY TEST ABNORMAL	1.9% 1/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Investigations WEIGHT DECREASED	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders DIZZINESS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders DYSGEUSIA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders HEADACHE	1.9% 1/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	11.8% 2/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders HYPOAESTHESIA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	3.7% 2/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	13.3% 2/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	11.8% 2/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders OPTIC NEURITIS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders PAROSMIA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders SEDATION	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders SOMNOLENCE	1.9% 1/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Nervous system disorders TREMOR	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Psychiatric disorders AGITATION	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Psychiatric disorders INSOMNIA	1.9% 1/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	13.3% 2/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Psychiatric disorders LIBIDO DISORDER	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Psychiatric disorders SLEEP DISORDER	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Reproductive system and breast disorders EJACULATION DISORDER	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Reproductive system and breast disorders METRORRHAGIA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Respiratory, thoracic and mediastinal disorders HICCUPS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Respiratory, thoracic and mediastinal disorders YAWNING	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	11.8% 2/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	13.3% 2/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.9% 1/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Skin and subcutaneous tissue disorders SKIN LESION	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	5.0% 1/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
Vascular disorders FLUSHING	0.00% 0/54 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	6.7% 1/15 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/20 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.	0.00% 0/17 The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

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