Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Comp... | NCT02605174

ID	Type	Description
H8H-CD-LAHK	Other Identifier	Eli Lilly and Company
2015-005689-40	EudraCT Number
COL MIG-302	Other Identifier	Colucid

Status Module

Name	Class
CoLucid Pharmaceuticals	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lasmiditan 50 milligram (mg)	Experimental	Oral tablet. Lasmiditan 50 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.	Drug: Lasmiditan 50 mg
Lasmiditan 100 mg	Experimental	Oral tablet. Lasmiditan 100 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.	Drug: Lasmiditan 100 mg
Lasmiditan 200 mg	Experimental	Oral tablet. Lasmiditan 200 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.	Drug: Lasmiditan 200 mg
Placebo	Placebo Comparator	Oral tablet. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Lasmiditan 50 mg	Drug	One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)	Lasmiditan 50 milligram (mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Headache Pain Free at 2 Hours Post Dose	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

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants With Headache Relief	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
Number of Participants With Headache Recurrence

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to give written informed consent and authorize HIPAA.
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.
Migraine Disability Association (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 to record details of the migraine attack treated with study drug.

Exclusion Criteria:

Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
Pregnant or breast-feeding women.
Women of child-bearing potential not using or not willing to use highly effective contraception.
Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
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 Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.
Previous participation in this clinical trial.
Participation in any clinical trial of an experimental drug or device in the previous 30 days.
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 ≥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.
Participants who are employees of the sponsor.
Relatives of, or staff directly reporting to, the Investigator.

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
Alabama Clinical Therapeutics, LLC		Birmingham	Alabama	35235	United States
Medical Affiliated Research Center, Inc. - ARC

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	Lasmiditan 50 Milligram (mg)/Lasmiditan 50 mg	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.
FG001	Lasmiditan 50 mg/Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 30, 2015	May 29, 2018

Arm/Group Information

ID	Title	Description
BG000	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
BG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
BG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
BG003	Placebo	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 between 2 and 24 hours for rescue or recurrence of migraine.
BG004	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
	BG00042.8± 13.20 BG00143.4± 12.59 BG00241.8± 12.40 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000554 BG001539 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0003 BG0012 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG000135 BG001137 BG002

Region of Enrollment

Participants in each region are those who were randomized to each arm.

Count of Participants

Participants

Title

Denominators

Categories

Germany

Title	Measurements
	BG00077 BG00179 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 Headache Pain Free at 2 Hours Post Dose

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	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo	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 dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Units	Counts
Participants	OG000556 OG001532 OG002528 OG003

Title

Denominators

Categories

Title	Measurements
	OG00028.6 OG00131.4 OG00238.8 OG003

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 OG003		Regression, Logistic		0.003		Odds Ratio (OR)	1.5			2-Sided	95	1.1	1.9					Superiority
OG001 OG003		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	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo

Other Pre-specified

Percentage of Participants With Headache Relief

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	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo

Other Pre-specified

Number of Participants With Headache Recurrence

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)

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

Posted

Count of Participants

Participants

From 2 Hours Post Dose Up to 48 Hours

ID	Title	Description
OG000	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003

Other Pre-specified

Percentage of Participants Use of Rescue Medication

The percentage of participants who used rescue medication.

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

2 hours post dose

ID	Title	Description
OG000	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo

Other Pre-specified

Percentage of Participants Use of Rescue Medication

The percentage of participants who used rescue medication.

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

From 2 Hours Post Dose Up to 24 Hours

ID	Title	Description
OG000	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo

Other Pre-specified

Percentage of Participants Use of Rescue Medication

The percentage of participants who used rescue medication.

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

From 24 Post Dose Up to 48 Hours

ID	Title	Description
OG000	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo

Other Pre-specified

Percentage of Participants Nausea Free

The percentage of participant without nausea.

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

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo	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 between 2 and 24 hours for rescue or recurrence of migraine.

Other Pre-specified

Percentage of Participants With Phonophobia Free

The percentage of participants without phonophobia.

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

Posted

Number

percentage of participants

2 hours post dose

ID	Title	Description
OG000	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo

Other Pre-specified

Percentage of Participants With 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	Lasmiditan 50 mg	Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG001	Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
OG003	Placebo

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 had received at least one dose of study drug and had evaluable resource utilization data.

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	Lasmiditan 50 mg/Lasmiditan 50 mg	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.
OG001	Lasmiditan 50 mg/Placebo	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.
OG002	Lasmiditan 100 mg/Lasmiditan 100 mg	Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.

Other Pre-specified

Number of Participants With Treatment Emergent Events

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

Number

participants

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

ID	Title	Description
OG000	Lasmiditan 50 mg	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.
OG001	Lasmiditan 100 mg	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.
OG002	Lasmiditan 200 mg	Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional 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	Lasmiditan 50 mg/Lasmiditan 50 mg	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.	429	1	429	118	429
EG001	Lasmiditan 50 mg/Placebo	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	225	0	225	61	225
EG002	Lasmiditan 100 mg/Lasmiditan 100 mg	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.	423	1	423	149	423
EG003	Lasmiditan 100 mg/Placebo	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	212	1	212	94	212
EG004	Lasmiditan 200 mg/Lasmiditan 200 mg	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.	435	3	435	177	435
EG005	Lasmiditan 200 mg/Placebo	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	217	0	217	87	217
EG006	Placebo/Placebo	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.	646	2	646	80	646

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG0030 events0 affected212 at risk EG0040 events0 affected435 at risk EG0050 events0 affected217 at risk EG0061 events1 affected646 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Presyncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Somatisation disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Surgery	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0004 events3 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG0031 events1 affected212 at risk EG0041 events1 affected435 at risk EG0052 events1 affected217 at risk EG0061 events1 affected646 at risk
Tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0022 events2 affected423 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Motion sickness	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected225 at risk EG0023 events3 affected423 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Blepharospasm	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Chromatopsia	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Keratitis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Mydriasis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Photopsia	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Strabismus	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Vision blurred	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Visual impairment	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0021 events1 affected423 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0022 events1 affected423 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events2 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00012 events12 affected429 at risk EG0016 events6 affected225 at risk EG00213 events13 affected423 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected429 at risk EG0014 events4 affected225 at risk EG0022 events2 affected423 at risk EG003
Asthenia	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected429 at risk EG0012 events2 affected225 at risk EG0022 events2 affected423 at risk EG003
Chest discomfort	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0012 events2 affected225 at risk EG0020 events0 affected423 at risk EG003
Chills	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Face oedema	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG00013 events13 affected429 at risk EG0017 events7 affected225 at risk EG00213 events13 affected423 at risk EG003
Feeling abnormal	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0012 events2 affected225 at risk EG0023 events3 affected423 at risk EG003
Feeling cold	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Feeling hot	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0022 events2 affected423 at risk EG003
Feeling jittery	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Gait disturbance	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Malaise	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Mass	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Peripheral swelling	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Sense of oppression	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Thirst	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0022 events1 affected423 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Hordeolum	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Laryngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Rhinitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected429 at risk EG0011 events1 affected225 at risk EG0022 events2 affected423 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0021 events1 affected423 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Blood pressure decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Blood pressure increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Heart rate increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Pulse pressure increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0023 events3 affected423 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected429 at risk EG0011 events1 affected225 at risk EG0024 events4 affected423 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Aphasia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Ataxia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Aura	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Clumsiness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Coordination abnormal	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00042 events39 affected429 at risk EG00119 events18 affected225 at risk EG00284 events77 affected423 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Facial spasm	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Formication	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0023 events2 affected423 at risk EG003
Head discomfort	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0011 events1 affected225 at risk EG0021 events1 affected423 at risk EG003
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected429 at risk EG0010 events0 affected225 at risk EG0026 events5 affected423 at risk EG003
Lethargy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0008 events7 affected429 at risk EG0012 events2 affected225 at risk EG0024 events4 affected423 at risk EG003
Migraine	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Myoclonus	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00013 events11 affected429 at risk EG0017 events7 affected225 at risk EG00222 events21 affected423 at risk EG003
Presyncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Psychomotor hyperactivity	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Sedation	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0022 events2 affected423 at risk EG003
Sensory disturbance	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Somnolence	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00025 events24 affected429 at risk EG00111 events11 affected225 at risk EG00221 events21 affected423 at risk EG003
Stupor	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Tremor	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0022 events2 affected423 at risk EG003
Vertigo cns origin	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Abnormal dreams	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0003 events2 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Adjustment disorder with anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected429 at risk EG0011 events1 affected225 at risk EG0026 events6 affected423 at risk EG003
Burnout syndrome	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Delirium	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Depersonalisation	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Disorientation	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Euphoric mood	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected429 at risk EG0010 events0 affected225 at risk EG0025 events5 affected423 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Hallucination, visual	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Hypervigilance	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Mood swings	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Nightmare	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Panic reaction	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0012 events2 affected225 at risk EG0022 events2 affected423 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Sleep terror	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Nasal odour	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0011 events1 affected225 at risk EG0020 events0 affected423 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0021 events1 affected423 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0012 events2 affected225 at risk EG0020 events0 affected423 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Flushing	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003
Hot flush	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected429 at risk EG0012 events2 affected225 at risk EG0021 events1 affected423 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected429 at risk EG0010 events0 affected225 at risk EG0020 events0 affected423 at risk EG003