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Clinical Trial Results:
A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

Summary
EudraCT number	2015-005689-40
Trial protocol	GB DE
Global end of trial date	30 Jun 2017

Results information
Results version number	v1(current)
This version publication date	15 Jul 2018
First version publication date	15 Jul 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

H8H-CD-LAHK

ISRCTN number

US NCT number

NCT02605174

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16889

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877-CTLILLY, ClinicalTrials.gov@lilly.com

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877-285-4559, ClinicalTrials.gov@lilly.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

30 Jun 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

30 Jun 2017

Was the trial ended prematurely?

Main objective of the trial

Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of screening with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and End-of-Study (EoS) within one week (7 days) of treating a single migraine attack. The total time on study is approximately up to 11 weeks.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 May 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 310

Country: Number of subjects enrolled

United Kingdom: 191

Country: Number of subjects enrolled

United States: 2504

Worldwide total number of subjects

3005

EEA total number of subjects

501

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

2855

From 65 to 84 years

150

85 years and over

Subject disposition

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Recruitment details

No Text Entered

Screening details

Participants were randomly assigned to 1 of 7 sequences and received lasmiditan 50 mg (L50 mg), lasmiditan 100 mg (L100 mg) or lasmiditan 200 mg (L200 mg) or placebo (P) for the first dose and the second dose, if needed for rescue or recurrence of migraine.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Lasmiditan 50 milligram (mg)/Lasmiditan 50 mg

Arm description

Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Arm type

Experimental

Investigational medicinal product name

Lasmitidan

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Lasmiditan 50 mg/Placebo

Arm description

Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Lasmiditan 100 mg/Lasmiditan 100 mg

Arm description

Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Arm type

Experimental

Investigational medicinal product name

Lasmiditan 100 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Lasmitidan 100 mg/Placebo

Arm description

Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Lasmiditan 200 mg/Lasmiditan 200 mg

Arm description

Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Arm type

Experimental

Investigational medicinal product name

Lasmiditan 200 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Lasmitidan 200 mg/Placebo

Arm description

Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Placebo/Placebo

Arm description

Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, daily for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Number of subjects in period 1	Lasmiditan 50 milligram (mg)/Lasmiditan 50 mg	Lasmiditan 50 mg/Placebo	Lasmiditan 100 mg/Lasmiditan 100 mg	Lasmitidan 100 mg/Placebo	Lasmiditan 200 mg/Lasmiditan 200 mg	Lasmitidan 200 mg/Placebo	Placebo/Placebo
Started	501	249	502	252	501	249	751
Received at Least 1 Dose of Study Drug	429 ^[1]	225 ^[2]	423 ^[3]	212 ^[4]	434 ^[5]	215 ^[6]	645 ^[7]
Received Optional 2nd Dose	206 ^[8]	96 ^[9]	177 ^[10]	83 ^[11]	144 ^[12]	74 ^[13]	361 ^[14]
Completed	437	226	426	216	448	217	662
Not completed	64	23	76	36	53	32	89
Consent withdrawn by subject	9	6	14	11	6	4	15
Physician decision	2	-	-	-	-	-	3
Adverse event, non-fatal	-	-	1	-	4	-	-
Pregnancy	1	-	-	2	-	-	-
Randomization Failure	22	6	20	7	16	11	30
Lost to follow-up	20	7	27	10	20	10	29
Protocol deviation	10	4	14	6	7	7	12

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: One site was burned down and several participants have incomplete data.
[7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.
[14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants who completed the study was adjusted due to one site which burned down and therefore several participants have incomplete data. All participants who received at least one dose of study drug and all participants who received a 2nd dose are subset to those participants who started the study.

Baseline characteristics

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Reporting group title

Overall Study

Reporting group description

All randomized participants who received at least one dose of study drug.

Reporting group values	Overall Study	Total
Number of subjects	3005	3005
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	2855	2855
From 65-84 years	150	150
85 years and over	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	42.3 ( 12.93 )	-
Gender categorical
Units: Subjects
Female	2515	2515
Male	490	490
Race/Ethnicity, Customized
Race at baseline
Units: Subjects
American Indian or Alaska Native	18	18
Asian	26	26
Black or African American	522	522
Native Hawaiian or other Pacific Islander	11	11
White	2370	2370
Other	28	28
Multiple	23	23
Missing	7	7
Race/Ethnicity, Customized
Ethnicity at baseline
Units: Subjects
Hispanic or Latino	610	610
Not Hispanic or Latino	2373	2373
Not Reported	10	10
Unknown	5	5
Missing	7	7
Region of Enrollment
Units: Subjects
Germany	310	310
United Kingdom	191	191
United States	2504	2504

End points

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Reporting group title

Lasmiditan 50 milligram (mg)/Lasmiditan 50 mg

Reporting group description

Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmiditan 50 mg/Placebo

Reporting group description

Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmiditan 100 mg/Lasmiditan 100 mg

Reporting group description

Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmitidan 100 mg/Placebo

Reporting group description

Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmiditan 200 mg/Lasmiditan 200 mg

Reporting group description

Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmitidan 200 mg/Placebo

Reporting group description

Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Placebo/Placebo

Reporting group description

Subject analysis set title

Lasmiditan 50 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug, had evaluable headache pain free data and were treated for a qualifying migraine within 4 hours of onset.

Subject analysis set title

Lasmiditan 100 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug, had evaluable headache pain free data and were treated for a qualifying migraine within 4 hours of onset.

Subject analysis set title

Lasmiditan 200 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug, had evaluable headache pain free data and were treated for a qualifying migraine within 4 hours of onset.

Subject analysis set title

Placebo

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug, had evaluable headache pain free data and were treated for a qualifying migraine within 4 hours of onset.

Subject analysis set title

Lasmiditan 50 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug, had evaluable most bothersome symptoms (MBS) data and were treated for a qualifying migraine within 4 hours of onset.

Subject analysis set title

Lasmiditan 100 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug, had evaluable MBS data and were treated for a qualifying migraine within 4 hours of onset.

Subject analysis set title

Lasmiditan 200 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug, had evaluable MBS data and were treated for a qualifying migraine within 4 hours of onset.

Subject analysis set title

Placebo

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug, had evaluable MBS data and were treated for a qualifying migraine within 4 hours of onset.

Subject analysis set title

Lasmiditan 50 mg

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug and had evaluable post-dose headache severity or symptom assessments.

Subject analysis set title

Lasmiditan 100 mg

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug and had evaluable post-dose headache severity or symptom assessments.

Subject analysis set title

Lasmiditan 200 mg

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug and had evaluable post-dose headache severity or symptom assessments.

Subject analysis set title

Placebo

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug and had evaluable post-dose headache severity or symptom assessments.

Subject analysis set title

Lasmiditan 50 mg

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug and had evaluable post-dose headache severity or symptom assessments.

Subject analysis set title

Lasmiditan 100 mg

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug and had evaluable post-dose headache severity or symptom assessments.

Subject analysis set title

Lasmiditan 200 mg

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug and had evaluable post-dose headache severity or symptom assessments.

Subject analysis set title

Placebo

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized participants who received at least one dose of study drug and had evaluable post-dose headache severity or symptom assessments.

Subject analysis set title

Lasmiditan 50 mg

Subject analysis set type

Safety analysis

Subject analysis set description

All randomized participants who received study drug (first dose).

Subject analysis set title

Lasmiditan 100 mg

Subject analysis set type

Safety analysis

Subject analysis set description

All randomized participants who received study drug (first dose).

Subject analysis set title

Lasmiditan 200 mg

Subject analysis set type

Safety analysis

Subject analysis set description

All randomized participants who received study drug (first dose).

Subject analysis set title

Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

All randomized participants who received study drug (first dose).

Primary: Percentage of Participants Headache Pain Free at 2 Hours Post Dose

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End point title

Percentage of Participants Headache Pain Free at 2 Hours Post Dose

End point description

The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

End point type

Primary

End point timeframe

2 hours post dose

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	556 ^[1]	532 ^[2]	528 ^[3]	539 ^[4]
Units: percentage of participants
number (not applicable)	29	31	39	21

Notes
[1] - All intent to treat (ITT) participants who treated a qualifying migraine within 4 hours of onset.
[2] - All ITT participants who treated a qualifying migraine within 4 hours of onset.
[3] - All ITT participants who treated a qualifying migraine within 4 hours of onset.
[4] - All ITT participants who treated a qualifying migraine within 4 hours of onset.

Lasmiditan 200 mg

Statistical analysis description

Statistical analysis for Lasmiditan 200 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 200 mg

Number of subjects included in analysis

1067

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

3.1

Lasmiditan 100 mg

Statistical analysis description

Statistical analysis for Lasmiditan 100 mg compared with placebo

Comparison groups

Lasmiditan 100 mg v Placebo

Number of subjects included in analysis

1071

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

2.2

Lasmiditan 50 mg

Statistical analysis description

Statistical analysis for Lasmiditan 50 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 50 mg

Number of subjects included in analysis

1095

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

1.1

upper limit

1.9

Primary: Percentage of participants who are most bothersome symptom (MBS) free

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End point title

Percentage of participants who are most bothersome symptom (MBS) free

End point description

The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.

End point type

Primary

End point timeframe

2 hours post dose

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	512 ^[5]	500 ^[6]	483 ^[7]	514 ^[8]
Units: percentage of participants
number (not applicable)	41	44	49	33

Notes
[5] - All ITT participants who treated a qualifying migraine within 4 hours of onset.
[6] - All ITT participants who treated a qualifying migraine within 4 hours of onset.
[7] - All ITT participants who treated a qualifying migraine within 4 hours of onset.
[8] - All ITT participants who treated a qualifying migraine within 4 hours of onset.

Lasmiditan 200 mg

Statistical analysis description

Statistical analysis for Lasmiditan 200 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 200 mg

Number of subjects included in analysis

997

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

2.4

Lasmiditan 100 mg

Statistical analysis description

Statistical analysis for Lasmiditan 100 mg compared with placebo

Comparison groups

Lasmiditan 100 mg v Placebo

Number of subjects included in analysis

1014

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.6

Confidence interval

level

95%

sides

2-sided

lower limit

1.2

upper limit

Lasmiditan 50 mg

Statistical analysis description

Statistical analysis for Lasmiditan 50 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 50 mg

Number of subjects included in analysis

1026

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.1

upper limit

1.8

Other pre-specified: Percentage of Participants with Headache relief

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End point title

Percentage of Participants with Headache relief

End point description

The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.

End point type

Other pre-specified

End point timeframe

2 hours post dose

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	598 ^[9]	571 ^[10]	565 ^[11]	576 ^[12]
Units: percentage of participants
number (not applicable)	59	65	65	48

Notes
[9] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[10] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[11] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[12] - All randomized participants received at least one dose of study drug and evaluable post-dose data.

Lasmiditan 200 mg

Statistical analysis description

Statistical analysis for Lasmiditan 200 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 200 mg

Number of subjects included in analysis

1141

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

3.1

Lasmiditan 100 mg

Statistical analysis description

Statistical analysis for Lasmiditan 100 mg compared with placebo

Comparison groups

Lasmiditan 100 mg v Placebo

Number of subjects included in analysis

1147

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.7

upper limit

2.9

Lasmiditan 50 mg

Statistical analysis description

Statistical analysis for Lasmiditan 50 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 50 mg

Number of subjects included in analysis

1174

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

2.2

Other pre-specified: Number of Participants with Headache Recurrence

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End point title

Number of Participants with Headache Recurrence

End point description

The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose)

End point type

Other pre-specified

End point timeframe

From 2 Hours Post Dose Up to 48 Hours

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	159 ^[13]	167 ^[14]	205 ^[15]	115 ^[16]
Units: Participants
number (not applicable)	38	44	52	26

Notes
[13] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[14] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[15] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[16] - All randomized participants received at least one dose of study drug and evaluable post-dose data.

No statistical analyses for this end point

Other pre-specified: Percentage of Participants Use of rescue medication

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End point title

Percentage of Participants Use of rescue medication

End point description

The percentage of participants who used rescue medication.

End point type

Other pre-specified

End point timeframe

2 hours post dose

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	598 ^[17]	571 ^[18]	565 ^[19]	576 ^[20]
Units: percentage of participants
number (not applicable)	32	26	19	41

Notes
[17] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[18] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[19] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[20] - All randomized participants received at least one dose of study drug and evaluable post-dose data.

Lasmiditan 200 mg

Statistical analysis description

Statistical analysis for Lasmiditan 200 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 200 mg

Number of subjects included in analysis

1141

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

0.4

Lasmiditan 100 mg

Statistical analysis description

Statistical analysis for Lasmiditan 100 mg compared with placebo

Comparison groups

Lasmiditan 100 mg v Placebo

Number of subjects included in analysis

1147

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.7

Lasmiditan 50 mg

Statistical analysis description

Statistical analysis for Lasmiditan 50 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 50 mg

Number of subjects included in analysis

1174

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

0.9

Other pre-specified: Percentage of Participants Use of rescue medication

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End point title

Percentage of Participants Use of rescue medication

End point description

The percentage of participants who used rescue medication.

End point type

Other pre-specified

End point timeframe

From 2 Hours Post Dose Up to 24 Hours

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	598 ^[21]	571 ^[22]	565 ^[23]	576 ^[24]
Units: percentage of participants
number (not applicable)	9	6	7	9

Notes
[21] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[22] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[23] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[24] - All randomized participants received at least one dose of study drug and evaluable post-dose data.

Lasmiditan 200 mg

Statistical analysis description

Statistical analysis for Lasmiditan 200 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 200 mg

Number of subjects included in analysis

1141

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.456

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.6

upper limit

1.3

Lasmiditan 100 mg

Statistical analysis description

Statistical analysis for Lasmiditan 100 mg compared with placebo

Comparison groups

Lasmiditan 100 mg v Placebo

Number of subjects included in analysis

1147

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.129

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

1.1

Lasmiditan 50 mg

Statistical analysis description

Statistical analysis for Lasmiditan 50 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 50 mg

Number of subjects included in analysis

1174

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.917

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.5

Other pre-specified: Percentage of Participants Use of rescue medication

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End point title

Percentage of Participants Use of rescue medication

End point description

The percentage of participants who used rescue medication.

End point type

Other pre-specified

End point timeframe

From 24 Post Dose Up to 48 Hours

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	598 ^[25]	571 ^[26]	565 ^[27]	576 ^[28]
Units: percentage of participants
number (not applicable)	0	0	0	0

Notes
[25] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[26] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[27] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[28] - All randomized participants received at least one dose of study drug and evaluable post-dose data.

No statistical analyses for this end point

Other pre-specified: Percentage of participants nausea free

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End point title

Percentage of participants nausea free

End point description

The percentage of participant without nausea.

End point type

Other pre-specified

End point timeframe

2 hours post dose

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	598 ^[29]	571 ^[30]	565 ^[31]	576 ^[32]
Units: percentage of participants
number (not applicable)	69	72	70	70

Notes
[29] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[30] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[31] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[32] - All randomized participants received at least one dose of study drug and evaluable post-dose data.

Lasmiditan 200 mg

Statistical analysis description

Statistical analysis for Lasmiditan 200 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 200 mg

Number of subjects included in analysis

1141

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.992

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

1.3

Lasmiditan 100 mg

Statistical analysis description

Statistical analysis for Lasmiditan 100 mg compared with placebo

Comparison groups

Lasmiditan 100 mg v Placebo

Number of subjects included in analysis

1147

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.622

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

1.4

Lasmiditan 50 mg

Statistical analysis description

Statistical analysis for Lasmiditan 50 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 50 mg

Number of subjects included in analysis

1174

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.522

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.2

Other pre-specified: Percentage of participants with phonophobia free

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End point title

Percentage of participants with phonophobia free

End point description

The percentage of participants without phonophobia.

End point type

Other pre-specified

End point timeframe

2 hours post dose

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	598 ^[33]	571 ^[34]	565 ^[35]	576 ^[36]
Units: percentage of participants
number (not applicable)	61	65	65	53

Notes
[33] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[34] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[35] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[36] - All randomized participants received at least one dose of study drug and evaluable post-dose data.

Lasmiditan 200 mg

Statistical analysis description

Statistical analysis for Lasmiditan 200 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 200 mg

Number of subjects included in analysis

1141

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.6

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

2.1

Lasmiditan 100 mg

Statistical analysis description

Statistical analysis for Lasmiditan 100 mg compared with placebo

Comparison groups

Lasmiditan 100 mg v Placebo

Number of subjects included in analysis

1147

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.6

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

Lasmiditan 50 mg

Statistical analysis description

Statistical analysis for Lasmiditan 50 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 50 mg

Number of subjects included in analysis

1174

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.1

upper limit

1.7

Other pre-specified: Percentage of participants with photophobia free

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End point title

Percentage of participants with photophobia free

End point description

The percentage of participants without photophobia.

End point type

Other pre-specified

End point timeframe

2 hours post dose

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	598 ^[37]	571 ^[38]	565 ^[39]	576 ^[40]
Units: percentage of participants
number (not applicable)	51	56	58	43

Notes
[37] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[38] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[39] - All randomized participants received at least one dose of study drug and evaluable post-dose data.
[40] - All randomized participants received at least one dose of study drug and evaluable post-dose data.

Lasmiditan 200 mg

Statistical analysis description

Statistical analysis for Lasmiditan 200 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 200 mg

Number of subjects included in analysis

1141

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

2.3

Lasmiditan 100 mg

Statistical analysis description

Statistical analysis for Lasmiditan 100 mg compared with placebo

Comparison groups

Lasmiditan 100 mg v Placebo

Number of subjects included in analysis

1147

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

2.1

Lasmiditan 50 mg

Statistical analysis description

Statistical analysis for Lasmiditan 50 mg compared with placebo

Comparison groups

Placebo v Lasmiditan 50 mg

Number of subjects included in analysis

1174

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.1

upper limit

1.7

Other pre-specified: Percentage of Participants with Resource Utilization

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End point title

Percentage of Participants with Resource Utilization

End point description

Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study

End point type

Other pre-specified

End point timeframe

6 months prior to enrolling in study to End of Study (within 7 days of treating a single migraine attack)

End point values	Lasmiditan 50 milligram (mg)/Lasmiditan 50 mg	Lasmiditan 50 mg/Placebo	Lasmiditan 100 mg/Lasmiditan 100 mg	Lasmitidan 100 mg/Placebo	Lasmiditan 200 mg/Lasmiditan 200 mg	Lasmitidan 200 mg/Placebo	Placebo/Placebo
Number of subjects analysed	429 ^[41]	225 ^[42]	423 ^[43]	212 ^[44]	434 ^[45]	215 ^[46]	645 ^[47]
Units: percentage of participants
number (not applicable)
6 months prior to enrolling	5	2	3	2	3	3	3
During time of study	1	0	1	0	1	1	1

Notes
[41] - All randomized participants who had received at least one dose of study drug.
[42] - All randomized participants who had received at least one dose of study drug.
[43] - All randomized participants who had received at least one dose of study drug.
[44] - All randomized participants who had received at least one dose of study drug.
[45] - All randomized participants who had received at least one dose of study drug.
[46] - All randomized participants who had received at least one dose of study drug.
[47] - All randomized participants who had received at least one dose of study drug.

No statistical analyses for this end point

Other pre-specified: Number of Participants with Treatment Emergent Events

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End point title

Number of Participants with Treatment Emergent Events

End point description

Safety and Tolerability was assessed by the number of participants with at least 1 TEAE. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section

End point type

Other pre-specified

End point timeframe

From Baseline Up to End of Study (Up to 11 Weeks)

End point values	Lasmiditan 50 mg	Lasmiditan 100 mg	Lasmiditan 200 mg	Placebo
Number of subjects analysed	654 ^[48]	635 ^[49]	649 ^[50]	645 ^[51]
Units: participants
number (not applicable)	167	230	253	75

Notes
[48] - All randomized participants who received study drug (first dose).
[49] - All randomized participants who received study drug (first dose).
[50] - All randomized participants who received study drug (first dose).
[51] - All randomized participants who received study drug (first dose).

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

The safety population includes all participants who received at least one dose of study drug and the optional second dose.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

Lasmitidan 50 mg; Lasmitidan 50 mg

Reporting group description

Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmitidan 50 mg; Placebo

Reporting group description

Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmitidan 100 mg; Lasmitidan 100 mg

Reporting group description

Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 100 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmitidan 100 mg; Placebo

Reporting group description

Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine

Reporting group title

Lasmitidan 200 mg; Lasmitidan 200 mg

Reporting group description

Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 200 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Lasmitidan 200 mg; Placebo

Reporting group description

Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Reporting group title

Placebo; Placebo

Reporting group description

Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered within 24 hours for rescue or recurrence of migraine.

Serious adverse events	Lasmitidan 50 mg; Lasmitidan 50 mg	Lasmitidan 50 mg; Placebo	Lasmitidan 100 mg; Lasmitidan 100 mg	Lasmitidan 100 mg; Placebo	Lasmitidan 200 mg; Lasmitidan 200 mg	Lasmitidan 200 mg; Placebo	Placebo; Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	1 / 423 (0.24%)	1 / 212 (0.47%)	3 / 435 (0.69%)	0 / 217 (0.00%)	2 / 646 (0.31%)
number of deaths (all causes)	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pituitary tumor benign
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
deep vein thrombosis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
hypotension
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
surgery
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
presyncope
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
intestinal obstruction
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
cholelithiasis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
somatisation disorder
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Lasmitidan 50 mg; Lasmitidan 50 mg	Lasmitidan 50 mg; Placebo	Lasmitidan 100 mg; Lasmitidan 100 mg	Lasmitidan 100 mg; Placebo	Lasmitidan 200 mg; Lasmitidan 200 mg	Lasmitidan 200 mg; Placebo	Placebo; Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	118 / 429 (27.51%)	61 / 225 (27.11%)	149 / 423 (35.22%)	94 / 212 (44.34%)	177 / 435 (40.69%)	87 / 217 (40.09%)	80 / 646 (12.38%)
Vascular disorders
circulatory collapse
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
flushing
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	1 / 435 (0.23%)	1 / 217 (0.46%)	2 / 646 (0.31%)
occurrences all number	0	0	0	1	1	1	3
hot flush
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	2 / 225 (0.89%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	3 / 646 (0.46%)
occurrences all number	2	2	1	0	0	0	3
hypertension
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	1	0	0	1
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	2 / 225 (0.89%)	2 / 423 (0.47%)	4 / 212 (1.89%)	8 / 435 (1.84%)	4 / 217 (1.84%)	1 / 646 (0.15%)
occurrences all number	2	2	2	4	8	4	1
chest discomfort
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	2 / 225 (0.89%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	2 / 217 (0.92%)	2 / 646 (0.31%)
occurrences all number	0	2	0	0	0	2	2
chills
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	2 / 646 (0.31%)
occurrences all number	0	0	0	0	0	0	2
face edema
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	0	1	0
fatigue
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	13 / 429 (3.03%)	7 / 225 (3.11%)	13 / 423 (3.07%)	15 / 212 (7.08%)	21 / 435 (4.83%)	12 / 217 (5.53%)	6 / 646 (0.93%)
occurrences all number	13	7	13	15	21	12	6
feeling abnormal
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	2 / 225 (0.89%)	3 / 423 (0.71%)	1 / 212 (0.47%)	4 / 435 (0.92%)	1 / 217 (0.46%)	1 / 646 (0.15%)
occurrences all number	0	2	3	1	4	1	1
feeling cold
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	1 / 646 (0.15%)
occurrences all number	0	0	1	0	0	1	1
feeling hot
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	2 / 423 (0.47%)	0 / 212 (0.00%)	3 / 435 (0.69%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	2	0	3	0	0
feeling jittery
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	2 / 435 (0.46%)	2 / 217 (0.92%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	2	2	0
gait disturbance
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	2 / 435 (0.46%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	2	1	0
malaise
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	1	0	0
mass
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
non-cardiac chest pain
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	2 / 435 (0.46%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	2	0	0
peripheral swelling
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	1	0	0	0
pyrexia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
sense of oppression
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
thirst
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	1	2	0	0	1	0
Reproductive system and breast disorders
menorrhagia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed ^[1]	1 / 351 (0.28%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	2 / 364 (0.55%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	2	0	0
ovarian cyst
alternative dictionary used: MedDRA 18.0
subjects affected / exposed ^[2]	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 357 (0.28%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
postmenopausal haemorrhage
alternative dictionary used: MedDRA 18.0
subjects affected / exposed ^[3]	0 / 406 (0.00%)	0 / 224 (0.00%)	1 / 420 (0.24%)	0 / 212 (0.00%)	0 / 414 (0.00%)	0 / 202 (0.00%)	0 / 633 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
cough
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	0	0	0	0	0
dyspnea
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
epistaxis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
nasal congestion
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
nasal odour
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	0	0	0	0	0
oropharyngeal pain
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	0	0	1
paranasal sinus discomfort
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	1	0	0	0
respiratory tract congestion
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
sinus congestion
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
throat tightness
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	0	0	1
Psychiatric disorders
abnormal dreams
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	3	0	1	0	0	0	0
adjustment disorder
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
adjustment disorder with anxiety
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
anxiety
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	1 / 225 (0.44%)	6 / 423 (1.42%)	0 / 212 (0.00%)	3 / 435 (0.69%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	2	1	6	0	3	1	0
burnout syndrome
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
confusional state
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	1	0	0
delirium
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	0	0	0	0	0
depersonalization
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
depressed mood
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
disorientation
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	2 / 217 (0.92%)	1 / 646 (0.15%)
occurrences all number	0	0	1	0	1	2	1
euphoric mood
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	0 / 225 (0.00%)	5 / 423 (1.18%)	0 / 212 (0.00%)	2 / 435 (0.46%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	2	0	5	0	2	1	0
hallucination
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	1	0	0
hallucination, visual
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	1	1	0	0
hypervigilance
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
insomnia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	3 / 435 (0.69%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	3	0	0
mental disorder
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	0	1	0
mental status changes
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
mood swings
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
nightmare
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
panic attack
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	1	0
panic reaction
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
restlessness
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	2 / 225 (0.89%)	2 / 423 (0.47%)	3 / 212 (1.42%)	3 / 435 (0.69%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	2	2	3	3	0	0
sleep disorder
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
sleep terror
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	0	0	1	0	0
suicidal ideation
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Investigations
blood pressure decreased
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	1	0	0	0
blood pressure increased
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
heart rate increased
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	1 / 212 (0.47%)	1 / 435 (0.23%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	1	1	1	0	1
pulse pressure increased
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Injury, poisoning and procedural complications
arthropod sting
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
contusion
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	0	0	1
ligament sprain
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
skin abrasion
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	0	0	0	0	0
tendon injury
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Cardiac disorders
palpitations
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	3 / 429 (0.70%)	0 / 225 (0.00%)	1 / 423 (0.24%)	1 / 212 (0.47%)	1 / 435 (0.23%)	1 / 217 (0.46%)	1 / 646 (0.15%)
occurrences all number	4	0	1	1	1	2	1
tachycardia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	2 / 423 (0.47%)	0 / 212 (0.00%)	1 / 435 (0.23%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	1	2	0	1	1	0
Nervous system disorders
aphasia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	0	1	0
ataxia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	2 / 435 (0.46%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	2	0	0
aura
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
balance disorder
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	2 / 435 (0.46%)	2 / 217 (0.92%)	0 / 646 (0.00%)
occurrences all number	1	0	1	0	2	2	0
clumsiness
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
cognitive disorder
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	2 / 435 (0.46%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	2	0	0
coordination abnormal
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	2 / 212 (0.94%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	2	0	0	0
disturbance in attention
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
dizziness
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	39 / 429 (9.09%)	18 / 225 (8.00%)	77 / 423 (18.20%)	45 / 212 (21.23%)	89 / 435 (20.46%)	33 / 217 (15.21%)	16 / 646 (2.48%)
occurrences all number	42	19	84	45	94	33	17
dysesthesia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	1	0	0
dysarthria
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	2 / 212 (0.94%)	2 / 435 (0.46%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	2	2	1	0
dysgeusia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	2 / 646 (0.31%)
occurrences all number	0	1	0	1	0	0	2
facial spasm
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
formication
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	2 / 423 (0.47%)	2 / 212 (0.94%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	3	2	0	1	0
head discomfort
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	1 / 225 (0.44%)	1 / 423 (0.24%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	1	1	1	1	0	0	1
headache
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	3 / 435 (0.69%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	2	0	1	0	3	0	1
hypoesthesia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	0 / 225 (0.00%)	5 / 423 (1.18%)	5 / 212 (2.36%)	10 / 435 (2.30%)	0 / 217 (0.00%)	2 / 646 (0.31%)
occurrences all number	2	0	6	5	10	0	2
lethargy
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	7 / 429 (1.63%)	2 / 225 (0.89%)	4 / 423 (0.95%)	4 / 212 (1.89%)	7 / 435 (1.61%)	7 / 217 (3.23%)	1 / 646 (0.15%)
occurrences all number	8	2	4	4	7	7	1
migraine
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	1	0	0
myoclonus
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
paresthesia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	11 / 429 (2.56%)	7 / 225 (3.11%)	21 / 423 (4.96%)	17 / 212 (8.02%)	30 / 435 (6.90%)	13 / 217 (5.99%)	6 / 646 (0.93%)
occurrences all number	13	7	22	17	34	14	6
presyncope
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
psychomotor hyperactivity
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
sedation
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	2 / 423 (0.47%)	2 / 212 (0.94%)	2 / 435 (0.46%)	2 / 217 (0.92%)	0 / 646 (0.00%)
occurrences all number	1	0	2	2	2	2	0
sensory disturbance
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	3 / 212 (1.42%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	3	0	0	0
somnolence
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	24 / 429 (5.59%)	11 / 225 (4.89%)	21 / 423 (4.96%)	10 / 212 (4.72%)	34 / 435 (7.82%)	12 / 217 (5.53%)	13 / 646 (2.01%)
occurrences all number	25	11	21	10	36	12	13
stupor
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	1	0	0	0
syncope
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	2	0	0	0	0	1	0
tremor
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	2 / 423 (0.47%)	0 / 212 (0.00%)	4 / 435 (0.92%)	2 / 217 (0.92%)	0 / 646 (0.00%)
occurrences all number	0	1	2	0	4	2	0
vertigo cns origin
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	0	1	0
Ear and labyrinth disorders
ear discomfort
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
motion sickness
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
tinnitus
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	1	1	0	0	1	0	1
vertigo
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	1 / 225 (0.44%)	3 / 423 (0.71%)	2 / 212 (0.94%)	3 / 435 (0.69%)	2 / 217 (0.92%)	1 / 646 (0.15%)
occurrences all number	1	1	3	3	3	2	1
Eye disorders
blepharospasm
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	0	0	1
chromatopsia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
keratitis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
mydriasis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	0	1	0
ocular hyperemia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	0	1	0
photopsia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	1	0
strabismus
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
vision blurred
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	1 / 423 (0.24%)	2 / 212 (0.94%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	1	2	1	0	0
visual acuity reduced
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
visual impairment
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	1 / 212 (0.47%)	2 / 435 (0.46%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	1	0	1	2	1	0
vitreous floaters
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
Gastrointestinal disorders
abdominal discomfort
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	1	0	1	0
abdominal pain
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	1 / 423 (0.24%)	2 / 212 (0.94%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	1	2	0	0	0
abdominal pain upper
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	2	0	1	0	1	1	0
diarrhoea
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	1 / 217 (0.46%)	1 / 646 (0.15%)
occurrences all number	0	0	2	0	1	1	2
dry mouth
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	0 / 225 (0.00%)	1 / 423 (0.24%)	1 / 212 (0.47%)	2 / 435 (0.46%)	1 / 217 (0.46%)	2 / 646 (0.31%)
occurrences all number	3	0	1	1	2	1	2
dyspepsia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	1	0	0	0	0
hypoesthesia oral
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
lip dry
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	0	0	0	0	0
nausea
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	12 / 429 (2.80%)	6 / 225 (2.67%)	13 / 423 (3.07%)	9 / 212 (4.25%)	14 / 435 (3.22%)	4 / 217 (1.84%)	9 / 646 (1.39%)
occurrences all number	12	6	13	9	14	4	9
paresthesia oral
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	3 / 435 (0.69%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	3	0	1
retching
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	0	0	1
toothache
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
vomiting
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	4 / 225 (1.78%)	2 / 423 (0.47%)	2 / 212 (0.94%)	3 / 435 (0.69%)	3 / 217 (1.38%)	3 / 646 (0.46%)
occurrences all number	2	4	2	2	3	3	3
Skin and subcutaneous tissue disorders
hyperhidrosis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	2 / 225 (0.89%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	2	0	0	0	0	1
pruritus
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	0	0	1
pruritus generalised
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	1	0	0	0
Renal and urinary disorders
urinary incontinence
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
Endocrine disorders
hyperthyroidism
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	2 / 646 (0.31%)
occurrences all number	0	0	0	0	1	0	2
back pain
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	2 / 435 (0.46%)	1 / 217 (0.46%)	1 / 646 (0.15%)
occurrences all number	0	0	1	0	2	1	1
muscle spasms
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	1	0	1	0	0
muscle twitching
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	3 / 423 (0.71%)	0 / 212 (0.00%)	2 / 435 (0.46%)	2 / 217 (0.92%)	1 / 646 (0.15%)
occurrences all number	0	0	3	0	2	2	1
muscular weakness
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	6 / 429 (1.40%)	1 / 225 (0.44%)	4 / 423 (0.95%)	4 / 212 (1.89%)	7 / 435 (1.61%)	2 / 217 (0.92%)	0 / 646 (0.00%)
occurrences all number	6	1	4	4	7	2	0
musculoskeletal chest pain
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	0	0	1	0	0
musculoskeletal pain
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	1	0	0	0	0	0
musculoskeletal stiffness
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	1	0	2
myalgia
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	1	0	0
neck pain
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	1	0
pain in extremity
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	1 / 212 (0.47%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	0	1	1	0	0
Infections and infestations
bronchitis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	1 / 429 (0.23%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	1	0	0	0	0	0	0
gastroenteritis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
hordeolum
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	1 / 217 (0.46%)	0 / 646 (0.00%)
occurrences all number	0	0	0	0	0	1	0
influenza
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	2 / 429 (0.47%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	2	0	0	0	0	0	0
laryngitis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	0	0	0
nasopharyngitis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	3 / 646 (0.46%)
occurrences all number	0	0	1	0	1	0	3
rhinitis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	0	0	1
sinusitis
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	1 / 212 (0.47%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	1	1	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	3 / 429 (0.70%)	1 / 225 (0.44%)	2 / 423 (0.47%)	2 / 212 (0.94%)	3 / 435 (0.69%)	2 / 217 (0.92%)	3 / 646 (0.46%)
occurrences all number	3	1	2	2	3	2	3
urinary tract infection
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	1 / 225 (0.44%)	1 / 423 (0.24%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	1	1	0	0	0	1
viral upper respiratory tract infection
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	0 / 423 (0.00%)	0 / 212 (0.00%)	0 / 435 (0.00%)	0 / 217 (0.00%)	1 / 646 (0.15%)
occurrences all number	0	0	0	0	0	0	1
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 18.0
subjects affected / exposed	0 / 429 (0.00%)	0 / 225 (0.00%)	1 / 423 (0.24%)	0 / 212 (0.00%)	1 / 435 (0.23%)	0 / 217 (0.00%)	0 / 646 (0.00%)
occurrences all number	0	0	1	0	1	0	0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of participants exposed has been adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of participants exposed has been adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of participants exposed has been adjusted accordingly.

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Headache Pain Free at 2 Hours Post Dose

Primary: Percentage of Participants Headache Pain Free at 2 Hours Post Dose

Primary: Percentage of participants who are most bothersome symptom (MBS) free

Primary: Percentage of participants who are most bothersome symptom (MBS) free

Other pre-specified: Percentage of Participants with Headache relief

Other pre-specified: Percentage of Participants with Headache relief

Other pre-specified: Number of Participants with Headache Recurrence

Other pre-specified: Number of Participants with Headache Recurrence

Other pre-specified: Percentage of Participants Use of rescue medication

Other pre-specified: Percentage of Participants Use of rescue medication

Other pre-specified: Percentage of Participants Use of rescue medication

Other pre-specified: Percentage of Participants Use of rescue medication

Other pre-specified: Percentage of Participants Use of rescue medication

Other pre-specified: Percentage of Participants Use of rescue medication

Other pre-specified: Percentage of participants nausea free

Other pre-specified: Percentage of participants nausea free

Other pre-specified: Percentage of participants with phonophobia free

Other pre-specified: Percentage of participants with phonophobia free

Other pre-specified: Percentage of participants with photophobia free

Other pre-specified: Percentage of participants with photophobia free

Other pre-specified: Percentage of Participants with Resource Utilization

Other pre-specified: Percentage of Participants with Resource Utilization

Other pre-specified: Number of Participants with Treatment Emergent Events

Other pre-specified: Number of Participants with Treatment Emergent Events

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)