Phase 2 Study of TD-9855 to Treat Fibromyalgia | NCT01693692

Label	Type	Description	Intervention Names
TD-9855 Group 1	Experimental	Group 1 to be dosed with TD-9855	Drug: TD-9855 Group 1
TD-9855 Group 2	Experimental	Group 2 to be dosed with TD-9855	Drug: TD-9855 Group 2
Placebo	Placebo Comparator	Group to be dosed with Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
TD-9855 Group 1	Drug		TD-9855 Group 1
TD-9855 Group 2

Measure	Description	Time Frame
Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries	Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.	Baseline and Week 6

Measure	Description	Time Frame
Fibromyalgia Impact Questionnaire (FIQ)	FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.	Day 43 (End of study treatment)
Patient Global Impression of Change (PGIC)

Name	Affiliation	Role
Medical Monitor	Theravance Biopharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Rheumatology Associates of North Alabama, PC		Huntsville	Alabama	35801	United States
Dedicated Clinical Research

PubMed Identifier	Type	Citation	Retractions
32856281	Derived	Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.

ID	Title	Description
FG000	Placebo	Participants will be administered a placebo once daily for 6 weeks.
FG001	TD-9855 Group 1	Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG00010 affected128 at risk EG00110 affected127 at risk EG00217 affected128 at risk
Nausea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0009 affected128 at risk EG00111 affected127 at risk EG00210 affected128 at risk
Dizziness	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0005 affected128 at risk EG0017 affected127 at risk EG00213 affected128 at risk
Insomnia	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected128 at risk EG0017 affected127 at risk EG00211 affected128 at risk
Constipation	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0016 affected127 at risk EG00212 affected128 at risk
Fatigue	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected128 at risk EG0016 affected127 at risk EG0029 affected128 at risk
Urinary tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0019 affected127 at risk EG0025 affected128 at risk
Decreased appetite	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0014 affected127 at risk EG0027 affected128 at risk
Nasopharyngitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0028 affected128 at risk
Tachycardia	Cardiac disorders	MedDRA (14.1)	Systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0027 affected128 at risk
Alanine aminotransferase increased	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0017 affected127 at risk EG0020 affected128 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0021 affected128 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Macrocytosis	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Palpitations	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0012 affected127 at risk EG0024 affected128 at risk
Postural orthostatic tachycardia syndrome	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0022 affected128 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Hypothyroidism	Endocrine disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Vision blurred	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0014 affected127 at risk EG0021 affected128 at risk
Dry eye	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Blindness transient	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Cataract	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Conjunctivitis	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Visual impairment	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0006 affected128 at risk EG0015 affected127 at risk EG0023 affected128 at risk
Vomiting	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected128 at risk EG0013 affected127 at risk EG0024 affected128 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0012 affected127 at risk EG0025 affected128 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0021 affected128 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0022 affected128 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Dental discomfort	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Infrequent bowel movements	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Lip dry	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Lip pain	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Irritability	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0012 affected127 at risk EG0021 affected128 at risk
Oedema peripheral	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Pyrexia	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0021 affected128 at risk
Non-cardiac chest pain	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Pain	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Asthenia	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Chills	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Sluggishness	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Tenderness	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Xerosis	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Hypersensitivity	Immune system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Seasonal allergy	Immune system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected128 at risk EG0013 affected127 at risk EG0024 affected128 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0010 affected127 at risk EG0022 affected128 at risk
Gastroenteritis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0022 affected128 at risk
Sinusitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0021 affected128 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Vaginal infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0022 affected128 at risk
Acute sinusitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Bacteriuria	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Bronchitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Ear infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Fungal infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Gingival infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Hordeolum	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Influenza	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Laryngitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Oral herpes	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Periumbilical abscess	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Pharyngitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Pneumonia	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Rhinitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Tooth abscess	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Tooth infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0022 affected128 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0022 affected128 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Procedural dizziness	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Blood pressure increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0012 affected127 at risk EG0022 affected128 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0014 affected127 at risk EG0020 affected128 at risk
Gamma-glutamyltransferase increase	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0013 affected127 at risk EG0021 affected128 at risk
Heart rate increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0021 affected128 at risk
Urinary sediment present	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0022 affected128 at risk
Weight decreased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Weight increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0021 affected128 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Blood creatine increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Blood pressure decreased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Cardiac murmur	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Heart sounds abnormal	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Hepatic enzyme increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Gout	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Hypovitaminosis	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Salt craving	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected128 at risk EG0014 affected127 at risk EG0023 affected128 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected128 at risk EG0011 affected127 at risk EG0021 affected128 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0013 affected127 at risk EG0020 affected128 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0021 affected128 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Invertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Disturbance in attention	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0015 affected127 at risk EG0020 affected128 at risk
Migraine	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0012 affected127 at risk EG0022 affected128 at risk
Sinus headache	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0013 affected127 at risk EG0020 affected128 at risk
Somnolence	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected128 at risk EG0011 affected127 at risk EG0021 affected128 at risk
Tremor	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0022 affected128 at risk
Dysgeusia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Memory impairment	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0021 affected128 at risk
Sciatica	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Sedation	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Dysaesthesia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Hyporeflexia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Loss of consciousness	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Neurological symptom	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Paraesthesia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Syncope	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Tension headache	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Anxiety	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0013 affected127 at risk EG0023 affected128 at risk
Abnormal dreams	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Affect lability	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Sleep disorder	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0022 affected128 at risk
Depressed mood	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Depression	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Euphoric mood	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Hallucination	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Hostility	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Illusion	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Libido decreased	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Thinking abnormal	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Haematuria	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0013 affected127 at risk EG0020 affected128 at risk
Micturition urgency	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0022 affected128 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Cystitis interstitial	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Dysuria	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Nocturia	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Proteinuria	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Hypomenorrhoea	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Menstrual disorder	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Menstruation delayed	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0013 affected127 at risk EG0021 affected128 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0023 affected128 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0023 affected128 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0022 affected128 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0020 affected128 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected128 at risk EG0010 affected127 at risk EG0020 affected128 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Hot flush	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected127 at risk EG0024 affected128 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0023 affected128 at risk
Flushing	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Hypotension	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

ID	Title	Description
BG000	Placebo	Participants will be administered a placebo once daily for 6 weeks.
BG001	TD-9855 Group 1	Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
BG002	TD-9855 Group 2	Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.
BG003	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	Placebo	Participants will be administered a placebo once daily for 6 weeks.	128	0	128	71	128
EG001	TD-9855 Group 1	Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	127	1	127	78	127
EG002	TD-9855 Group 2	Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.	128	1	128	90	128

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Transient neurological symptoms of unknown etiology	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment		EG0000 affected128 at risk EG0011 affected127 at risk EG0020 affected128 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment		EG0000 affected128 at risk EG0010 affected127 at risk EG0021 affected128 at risk