Lasmiditan Compared to Placebo in the Acute Treatment of... | NCT02439320

ID	Type	Description	Link
H8H-CD-LAHJ	Other Identifier	Eli Lilly and Company
COL MIG-301	Other Identifier	CoLucid Pharmaceuticals

Status Module

Name	Class
CoLucid Pharmaceuticals	INDUSTRY

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lasmiditan 100 mg	Experimental	Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.	Drug: Lasmiditan 100 mg Drug: Placebo (matches lasmiditan doses)
Lasmiditan 200 mg	Experimental	Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.	Drug: Lasmiditan 200 mg Drug: Placebo (matches lasmiditan doses)
Placebo	Placebo Comparator	Oral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.	Drug: Placebo (matches lasmiditan doses)

Name	Type	Description	Arm Group Labels	Other Names
Lasmiditan 100 mg	Drug		Lasmiditan 100 mg	LY573144
Lasmiditan 200 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Are Headache Pain Free	The percentage of participants defined as mild, moderate, or severe headache pain becoming none.	2 hours post dose
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.	2 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Have Headache Relief After First Dose	The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.	2 hours post dose
Percentage of Participants With Headache Recurrence

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants With Resource Utilization	Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study	6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to give written informed consent.
Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).
History of disabling migraine for at least 1 year.
MIDAS score ≥11.
Migraine onset before the age of 50 years.
History of 3 - 8 migraine attacks per month (< 15 headache days per month).
Male or female, aged 18 years or above.
Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
Able and willing to complete an electronic diary.

Exclusion Criteria:

Pregnant or breast-feeding women.
Women of child-bearing potential not using or not willing to use highly effective contraception.
Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.
History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
History of orthostatic hypotension with syncope.
Significant renal or hepatic impairment.
Participant is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit.
Known Hepatitis B or C or HIV infection.
History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is greater than 15 headache days per month.
Use of more than 3 doses per month of either opiates or barbiturates.
Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southview Medical Group, P.C.		Birmingham	Alabama	35205	United States
Simon-Williamson Clinic

PubMed Identifier	Type	Citation	Retractions
36125279	Derived	Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.
35779194	Derived

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
FG001	200 mg Lasmiditan

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose
BG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
BG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00042.2± 11.67 BG00141.4± 12.04 BG00242.4± 12.30 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000512 BG001515 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00082 BG00177 BG002

Race (NIH/OMB)

Unknown or Not reported row is listed as Other in the Clinical Study Report.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0007 BG0017 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000630 BG001609 BG002

Duration of Migraine History

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00019.7± 12.98 BG00118.9± 13.12 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Are Headache Pain Free

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

All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Units	Counts
Participants	OG000503 OG001518 OG002524

Title

Denominators

Categories

Title	Measurements
	OG00028.2 OG00132.2 OG00215.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Regression, Logistic		<0.001		Odds Ratio (OR)	2.2			2-Sided	95	1.6	3.0					Superiority
OG001 OG002		Regression, Logistic		<0.001

Primary

Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free

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

All randomized participants who received at least one dose of study drug and had evaluable MBS data.

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Percentage of Participants Who Have Headache Relief After First Dose

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

All randomized participants who received at least one dose of study drug and had evaluable headache relief data.

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Percentage of Participants With Headache Recurrence

Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.

Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

From 2 hours post dose up to 48 hours

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Percentage of Participants Who Used Rescue Medication

Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Percentage of Participants Who Used Rescue Medication

Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

Anytime between 2-24 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Percentage of Participants Who Used Rescue Medication

Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.

Posted

Number

percentage of participants

Anytime 24-48 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Percentage of Participants Nausea Free

The percentage of participants without nausea.

All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Percentage of Participants Phonophobia Free

The percentage of participants without phonophobia.

All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Percentage of Participants Photophobia Free

The percentage of participants without photophobia.

All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Secondary

Participants With Serious Adverse Events (SAE)

Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (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

All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.

Posted

Count of Participants

Participants

Baseline up to 11 weeks

ID	Title	Description
OG000	100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG001	200 mg Lasmiditan	200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
OG002	Placebo	Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.

Other Pre-specified

Percentage of Participants With Resource Utilization

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

All randomized participants who used at least 1 dose of study drug, regardless of whether or not they underwent any study assessments.

Posted

Number

percentage of participants

6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack

ID	Title	Description
OG000	100 mg Lasmiditan/100 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. An optional 100 mg Lasmiditan dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	100 mg Lasmiditan/Placebo	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	200 mg Lasmiditan/200 mg Lasmiditan	100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. An optional 100 mg lasmiditan dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	100 mg Lasmiditan	Any participant who received 100 milligrams (mg) lasmiditan administered PO.	630	0	630	258	630
EG001	200 mg Lasmiditan	Any participant who received 200 milligrams (mg) lasmiditan administered PO.	609	2	609	280	609
EG002	Placebo	Any participant who received placebo administered PO.	617	1	617	113	617

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Bradycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Cardiac flutter	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0014 events4 affected609 at risk EG0020 events0 affected617 at risk
Hyperacusis	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0022 events2 affected617 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0014 events4 affected609 at risk EG0021 events1 affected617 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected630 at risk EG0012 events2 affected609 at risk EG0020 events0 affected617 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Glaucoma	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Mydriasis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Photophobia	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0022 events2 affected617 at risk
Vision blurred	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0016 events6 affected609 at risk EG0020 events0 affected617 at risk
Visual impairment	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0012 events2 affected609 at risk EG0021 events1 affected617 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Bowel movement irregularity	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0022 events1 affected617 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0013 events3 affected609 at risk EG0020 events0 affected617 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0008 events8 affected630 at risk EG0011 events1 affected609 at risk EG0022 events2 affected617 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00019 events19 affected630 at risk EG00133 events33 affected609 at risk EG00216 events14 affected617 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0012 events2 affected609 at risk EG0024 events3 affected617 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00010 events10 affected630 at risk EG0017 events7 affected609 at risk EG0025 events5 affected617 at risk
Abasia	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Asthenia	General disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected630 at risk EG0017 events7 affected609 at risk EG0021 events1 affected617 at risk
Chest discomfort	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0012 events2 affected609 at risk EG0020 events0 affected617 at risk
Chills	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0012 events2 affected609 at risk EG0023 events3 affected617 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG00028 events28 affected630 at risk EG00121 events21 affected609 at risk EG0023 events3 affected617 at risk
Feeling abnormal	General disorders	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected630 at risk EG0014 events4 affected609 at risk EG0020 events0 affected617 at risk
Feeling cold	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0021 events1 affected617 at risk
Feeling drunk	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Feeling hot	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0021 events1 affected617 at risk
Feeling jittery	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected630 at risk EG0013 events3 affected609 at risk EG0021 events1 affected617 at risk
Feeling of relaxation	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Gait disturbance	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Malaise	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Thirst	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Breast cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Candida infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0021 events1 affected617 at risk
Cystitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Ear infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0021 events1 affected617 at risk
Otitis media	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0021 events1 affected617 at risk
Salmonellosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0024 events4 affected617 at risk
Tooth abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0013 events3 affected609 at risk EG0023 events3 affected617 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0010 events0 affected609 at risk EG0022 events2 affected617 at risk
Viral infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Exposure to toxic agent	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Blood pressure decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Cardiac murmur	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Heart rate increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Hepatic enzyme increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0021 events1 affected617 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0012 events2 affected609 at risk EG0020 events0 affected617 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0022 events2 affected617 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0013 events3 affected609 at risk EG0020 events0 affected617 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0012 events2 affected609 at risk EG0021 events1 affected617 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0015 events5 affected609 at risk EG0020 events0 affected617 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0009 events9 affected630 at risk EG00111 events10 affected609 at risk EG0020 events0 affected617 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0022 events2 affected617 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Ataxia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Aura	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Balance disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected630 at risk EG0017 events7 affected609 at risk EG0020 events0 affected617 at risk
Clumsiness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Cognitive disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Coordination abnormal	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Disturbance in attention	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00091 events87 affected630 at risk EG001114 events107 affected609 at risk EG00223 events22 affected617 at risk
Dysarthria	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0014 events4 affected609 at risk EG0020 events0 affected617 at risk
Dysgeusia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Dyskinesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0004 events4 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Fine motor skill dysfunction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0013 events3 affected609 at risk EG0022 events2 affected617 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Hypersomnia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0013 events3 affected609 at risk EG0020 events0 affected617 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00010 events9 affected630 at risk EG00113 events12 affected609 at risk EG0021 events1 affected617 at risk
Hypotonia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Lethargy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00016 events15 affected630 at risk EG00118 events17 affected609 at risk EG0023 events3 affected617 at risk
Mental impairment	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0012 events2 affected609 at risk EG0020 events0 affected617 at risk
Migraine	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0012 events2 affected609 at risk EG0023 events3 affected617 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00043 events42 affected630 at risk EG00151 events50 affected609 at risk EG00214 events14 affected617 at risk
Parosmia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Presyncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0014 events4 affected609 at risk EG0020 events0 affected617 at risk
Sedation	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected630 at risk EG0018 events8 affected609 at risk EG0021 events1 affected617 at risk
Sensory disturbance	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Sensory integrative dysfunction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Somnolence	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00040 events40 affected630 at risk EG00137 events36 affected609 at risk EG00214 events14 affected617 at risk
Tremor	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected630 at risk EG0014 events4 affected609 at risk EG0021 events1 affected617 at risk
Tunnel vision	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Visual field defect	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Affect lability	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Agitation	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0015 events5 affected609 at risk EG0021 events1 affected617 at risk
Apathy	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Blunted affect	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Confusional state	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0013 events3 affected609 at risk EG0020 events0 affected617 at risk
Depersonalisation	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Disorientation	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Dysphoria	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Euphoric mood	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected630 at risk EG0012 events2 affected609 at risk EG0020 events0 affected617 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Hypnagogic hallucination	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0012 events2 affected609 at risk EG0020 events0 affected617 at risk
Irritability	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Listless	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Nervousness	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Nightmare	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0013 events3 affected609 at risk EG0020 events0 affected617 at risk
Panic reaction	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Phonophobia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Restlessness	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0012 events2 affected609 at risk EG0020 events0 affected617 at risk
Sleep disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected525 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected525 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 events4 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0010 events0 affected609 at risk EG0020 events0 affected617 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 events4 affected630 at risk EG0011 events1 affected609 at risk EG0021 events1 affected617 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Skin sensitisation	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0011 events1 affected609 at risk EG0020 events0 affected617 at risk
Flushing	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected630 at risk EG0015 events5 affected609 at risk EG0022 events2 affected617 at risk
Hot flush	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected630 at risk EG0013 events3 affected609 at risk EG0023 events3 affected617 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected630 at risk EG0010 events0 affected609 at risk EG0021 events1 affected617 at risk