MT-8554 for Reduction of Vasomotor Symptoms in Postmenopa... | NCT03291067

Label	Type	Intervention Names
MT-8554 1mg	Experimental	Drug: MT-8554 1mg
MT-8554 5mg	Experimental	Drug: MT-8554 5mg
MT-8554 10mg	Experimental	Drug: MT-8554 10mg
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MT-8554 1mg	Drug	MT-8554 1mg QD, oral, 12 weeks	MT-8554 1mg
MT-8554 5mg

Measure	Description	Time Frame
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12	The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.	Baseline, Weeks 4 and 12
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12	The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.	Baseline, Weeks 4 and 12

Measure	Description	Time Frame
Percentage of Responders at Weeks 4 and 12	Subjects with cutoff number or greater reduction in the average daily frequency of moderate and severe VMS compared to baseline. The cutoff number was calculated using anchor-based method. The cutoff number was defined as numerical value to maximize the sensitivity and the specificity, using Patient Global Impression of Change (PGIC) as the anchor.	Week 4 and Week 12

Name	Affiliation	Role
Head of Medical Science	Tanabe Pharma America, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35209	United States
Research Site

ID	Title	Description
FG000	MT-8554 1mg	MT-8554 1mg QD, oral, 12 weeks
FG001	MT-8554 5mg	MT-8554 5mg QD, oral, 12 weeks

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 22, 2018	Oct 13, 2021

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

Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12

The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.

Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment

Posted

Least Squares Mean

Standard Error

VMS per day

Baseline, Weeks 4 and 12

ID	Title	Description
OG000	MT-8554 1mg	MT-8554 1mg QD, oral, 12 weeks
OG001	MT-8554 5mg	MT-8554 5mg QD, oral, 12 weeks
OG002	MT-8554 10mg	MT-8554 10mg QD, oral, 12 weeks
OG003	Placebo	Placebo QD, oral, 12 weeks

Units	Counts
Participants	OG00093 OG00190 OG00289 OG003

Title

Denominators

Categories

Week 4

Title	Measurements
	OG000-1.92± 0.609 OG001-2.75± 0.705 OG002-2.75± 0.734 OG003

Primary

Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12

The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.

Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment

Posted

Least Squares Mean

Standard Error

VMS severity score per day

Baseline, Weeks 4 and 12

ID	Title	Description
OG000	MT-8554 1mg	MT-8554 1mg QD, oral, 12 weeks
OG001	MT-8554 5mg	MT-8554 5mg QD, oral, 12 weeks
OG002	MT-8554 10mg	MT-8554 10mg QD, oral, 12 weeks

Secondary

Percentage of Responders at Weeks 4 and 12

Subjects with cutoff number or greater reduction in the average daily frequency of moderate and severe VMS compared to baseline. The cutoff number was calculated using anchor-based method. The cutoff number was defined as numerical value to maximize the sensitivity and the specificity, using Patient Global Impression of Change (PGIC) as the anchor.

Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment. The subjects without VMS frequency data at Week 4 were excluded from the analysis at Week 4. The subjects without VMS frequency data at Week 12 were excluded from the analysis at Week 12.

Posted

Number

percentage of subjects

Week 4 and Week 12

ID	Title	Description
OG000	MT-8554 1mg	MT-8554 1mg QD, oral, 12 weeks
OG001	MT-8554 5mg	MT-8554 5mg QD, oral, 12 weeks
OG002	MT-8554 10mg	MT-8554 10mg QD, oral, 12 weeks
OG003	Placebo

Secondary

Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12

The Insomnia Severity Index was a self-rated, 7-item validated sleep scale that measured clinical insomnia severity. The total score ranged from 0-28 where higher values indicated increased severity of insomnia.

Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Weeks 4 and 12

ID	Title	Description
OG000	MT-8554 1mg	MT-8554 1mg QD, oral, 12 weeks
OG001	MT-8554 5mg	MT-8554 5mg QD, oral, 12 weeks
OG002	MT-8554 10mg	MT-8554 10mg QD, oral, 12 weeks
OG003	Placebo	Placebo QD, oral, 12 weeks

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG0030 affected90 at risk
Goitre	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected95 at risk EG0012 affected90 at risk EG0020 affected93 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0022 affected93 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0022 affected93 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0012 affected90 at risk EG0024 affected93 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Oral discomfort	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0012 affected90 at risk EG00211 affected93 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Chills	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Cyst	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Feeling cold	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0012 affected90 at risk EG0023 affected93 at risk EG003
Feeling hot	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0027 affected93 at risk EG003
Feeling jittery	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Feeling of body temperature change	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Hypothermia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0022 affected93 at risk EG003
Malaise	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Bronchitis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Ear infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Furuncle	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0013 affected90 at risk EG0020 affected93 at risk EG003
Oral herpes	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Rhinitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected95 at risk EG0013 affected90 at risk EG0022 affected93 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0013 affected90 at risk EG0021 affected93 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Viral rhinitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0012 affected90 at risk EG0021 affected93 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Periorbital haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 affected95 at risk EG0012 affected90 at risk EG0020 affected93 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Biopsy endometrium abnormal	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 affected95 at risk EG0014 affected90 at risk EG0021 affected93 at risk EG003
Blood glucose increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Blood pressure increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Blood urine present	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Body temperature decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Electrocardiogram ST-T change	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Electrocardiogram T wave amplitude decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0022 affected93 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
International normalised ratio increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Neutrophil count increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Oestradiol increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Red blood cells urine positive	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Weight increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
White blood cell count increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
White blood cells urine positive	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0012 affected90 at risk EG0020 affected93 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0022 affected93 at risk EG003
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0025 affected93 at risk EG003
Migraine	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0012 affected90 at risk EG00214 affected93 at risk EG003
Parosmia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Sciatica	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Affect lability	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Irritability	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Nightmare	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Sleep inertia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Breast tenderness	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Allergic sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Pharyngeal hypoaesthesia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0022 affected93 at risk EG003
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0020 affected93 at risk EG003
Flushing	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0022 affected93 at risk EG003
Hot flush	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected95 at risk EG0010 affected90 at risk EG0023 affected93 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0011 affected90 at risk EG0021 affected93 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected95 at risk EG0010 affected90 at risk EG0022 affected93 at risk EG003

ID	Title	Description
BG000	MT-8554 1mg	MT-8554 1mg QD, oral, 12 weeks
BG001	MT-8554 5mg	MT-8554 5mg QD, oral, 12 weeks
BG002	MT-8554 10mg	MT-8554 10mg QD, oral, 12 weeks
BG003	Placebo	Placebo QD, oral, 12 weeks
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MT-8554 1mg	MT-8554 1mg QD, oral, 12 weeks	95	0	95	37	95
EG001	MT-8554 5mg	MT-8554 5mg QD, oral, 12 weeks	90	1	90	41	90
EG002	MT-8554 10mg	MT-8554 10mg QD, oral, 12 weeks	93	0	93	46	93
EG003	Placebo	Placebo QD, oral, 12 weeks	90	0	90	37	90