Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02314637
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Teneligliptin; Drug: Teneligliptin + Sulfonylurea	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teneligliptin Teneligliptin for 52 weeks	Drug: Teneligliptin; Teneligliptin for 52 weeks
Experimental: Teneligliptin + Sulfonylurea Teneligliptin for 52 weeks in combination with sulfonylurea	Drug: Teneligliptin + Sulfonylurea; Teneligliptin for 52 weeks in combination with sulfonylurea

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [52 weeks]

   Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.

Secondary Outcome Measures

1. Change From Baseline in HbA1c at Week 52 [Baseline and Week 52]

2. Change From Baseline in Fasting Plasma Glucose at Week 52 [Baseline and Week 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea for diabetes over 12 weeks before administration of investigational drug

• Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug

• HbA1c criteria:

• monotherapy: 6.9% - 10.5%

• combination therapy with Sulfonylurea: 7.4 - 10.5%

• Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

• Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)

• Patients who are accepting treatments of arrhythmias

• Patients with serious diabetic complications

• Patients who are the excessive alcohol addicts

• Patients with severe hepatic disorder or severe renal disorder

• Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reserch site	Shikoku		Japan

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: Takashi Kadowaki, Professor, Tokyo University
• Study Director: Kazuoki Kondo, MD, Mitsubishi Tanabe Pharma Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT02314637
• Other Study ID Numbers: 3000-A8
• First Posted: Dec 11, 2014
• Last Update Posted: Aug 20, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Mitsubishi Tanabe Pharma Corporation: DPP-IV inhibitor
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	Teneligliptin	Teneligliptin + Sulfonylurea
Arm/Group Description	Teneligliptin for 52 weeks	Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
Period Title: Overall Study
STARTED	151	89
COMPLETED	135	75
NOT COMPLETED	16	14

Baseline Characteristics

Arm/Group Title	Teneligliptin	Teneligliptin + Sulfonylurea	Total
Arm/Group Description	Teneligliptin for 52 weeks	Teneligliptin for 52 weeks in combination with sulfonylurea	Total of all reporting groups
Overall Participants	151	89	240
Age, Customized (participants) [Number]
<65 years	108 71.5%	65 73%	173 72.1%
>=65 years	43 28.5%	24 27%	67 27.9%
Sex: Female, Male (Count of Participants)
Female	56 37.1%	33 37.1%	89 37.1%
Male	95 62.9%	56 62.9%	151 62.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.

Arm/Group Title	Teneligliptin	Teneligliptin + Sulfonylurea
Arm/Group Description	Teneligliptin for 52 weeks	Teneligliptin for 52 weeks in combination with sulfonylurea
Measure Participants	151	89
Serious Adverse Event	6 4%	7 7.9%
Other Adverse Event	136 90.1%	84 94.4%

2. Secondary Outcome

Title	Change From Baseline in HbA1c at Week 52
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.

Arm/Group Title	Teneligliptin	Teneligliptin + Sulfonylurea
Arm/Group Description	Teneligliptin for 52 weeks	Teneligliptin for 52 weeks in combination with sulfonylurea
Measure Participants	151	89
Mean (Standard Deviation) [percent]	-0.63 (0.67)	-0.81 (0.76)

3. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose at Week 52
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.

Arm/Group Title	Teneligliptin	Teneligliptin + Sulfonylurea
Arm/Group Description	Teneligliptin for 52 weeks	Teneligliptin for 52 weeks in combination with sulfonylurea
Measure Participants	151	88
Mean (Standard Deviation) [mg/dL]	-12.4 (22.9)	-17.0 (30.5)

Adverse Events

Time Frame	52 weeks
Arm/Group Title	Teneligliptin		Teneligliptin + Sulfonylurea
Arm/Group Description	Teneligliptin for 52 weeks		Teneligliptin for 52 weeks in combination with sulfonylurea
All Cause Mortality
	Teneligliptin		Teneligliptin + Sulfonylurea
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Teneligliptin		Teneligliptin + Sulfonylurea
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/151 (4%)		7/89 (7.9%)
Ear and labyrinth disorders
Sudden hearing loss	1/151 (0.7%)		0/89 (0%)
Gastrointestinal disorders
Gastritis	1/151 (0.7%)		0/89 (0%)
Intestinal obstruction	1/151 (0.7%)		0/89 (0%)
Hepatobiliary disorders
Cholecystitis	0/151 (0%)		1/89 (1.1%)
Cholelithiasis	0/151 (0%)		1/89 (1.1%)
Infections and infestations
Diverticulitis	1/151 (0.7%)		0/89 (0%)
Injury, poisoning and procedural complications
Contusion	0/151 (0%)		1/89 (1.1%)
Joint sprain	0/151 (0%)		1/89 (1.1%)
Spinal compression fracture	0/151 (0%)		1/89 (1.1%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	1/151 (0.7%)		1/89 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer	0/151 (0%)		1/89 (1.1%)
Large intestine carcinoma	1/151 (0.7%)		0/89 (0%)
Testicular neoplasm	0/151 (0%)		1/89 (1.1%)
Nervous system disorders
Myelopathy	0/151 (0%)		1/89 (1.1%)
Other (Not Including Serious) Adverse Events
	Teneligliptin		Teneligliptin + Sulfonylurea
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	136/151 (90.1%)		84/89 (94.4%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/151 (0.7%)		0/89 (0%)
Cardiac disorders
Angina pectoris	0/151 (0%)		1/89 (1.1%)
Ear and labyrinth disorders
Meniere's disease	3/151 (2%)		0/89 (0%)
Tinnitus	2/151 (1.3%)		2/89 (2.2%)
Vertigo	4/151 (2.6%)		1/89 (1.1%)
Vertigo positional	1/151 (0.7%)		0/89 (0%)
Ear discomfort	1/151 (0.7%)		0/89 (0%)
Sudden hearing loss	1/151 (0.7%)		0/89 (0%)
Endocrine disorders
Thyroid mass	1/151 (0.7%)		0/89 (0%)
Eye disorders
Abnormal sensation in eye	0/151 (0%)		1/89 (1.1%)
Cataract	4/151 (2.6%)		0/89 (0%)
Conjunctival granuloma	1/151 (0.7%)		0/89 (0%)
Conjunctivitis	2/151 (1.3%)		0/89 (0%)
Conjunctivitis allergic	1/151 (0.7%)		1/89 (1.1%)
Diabetic retinopathy	2/151 (1.3%)		1/89 (1.1%)
Dry eye	0/151 (0%)		1/89 (1.1%)
Keratitis	0/151 (0%)		1/89 (1.1%)
Macular oedema	1/151 (0.7%)		0/89 (0%)
Strabismus	1/151 (0.7%)		0/89 (0%)
Vision blurred	1/151 (0.7%)		0/89 (0%)
Vitreous detachment	1/151 (0.7%)		0/89 (0%)
Vitreous floaters	0/151 (0%)		1/89 (1.1%)
Entropion	1/151 (0.7%)		0/89 (0%)
Gastrointestinal disorders
Abdominal discomfort	2/151 (1.3%)		1/89 (1.1%)
Abdominal distension	0/151 (0%)		1/89 (1.1%)
Abdominal pain upper	2/151 (1.3%)		1/89 (1.1%)
Anal fissure	1/151 (0.7%)		0/89 (0%)
Cheilitis	2/151 (1.3%)		1/89 (1.1%)
Colonic polyp	5/151 (3.3%)		3/89 (3.4%)
Constipation	5/151 (3.3%)		2/89 (2.2%)
Dental caries	2/151 (1.3%)		2/89 (2.2%)
Diarrhoea	6/151 (4%)		0/89 (0%)
Duodenal ulcer	0/151 (0%)		1/89 (1.1%)
Duodenitis	0/151 (0%)		1/89 (1.1%)
Dyspepsia	1/151 (0.7%)		2/89 (2.2%)
Enterocolitis	0/151 (0%)		1/89 (1.1%)
Faeces hard	1/151 (0.7%)		0/89 (0%)
Food poisoning	1/151 (0.7%)		0/89 (0%)
Gastric polyps	5/151 (3.3%)		5/89 (5.6%)
Gastritis	5/151 (3.3%)		6/89 (6.7%)
Gastritis erosive	1/151 (0.7%)		1/89 (1.1%)
Gingivitis	1/151 (0.7%)		1/89 (1.1%)
Haemorrhoids	3/151 (2%)		2/89 (2.2%)
Hiatus hernia	0/151 (0%)		1/89 (1.1%)
Inguinal hernia	1/151 (0.7%)		1/89 (1.1%)
Nausea	2/151 (1.3%)		0/89 (0%)
Periodontal disease	2/151 (1.3%)		1/89 (1.1%)
Periodontitis	1/151 (0.7%)		1/89 (1.1%)
Rectal polyp	0/151 (0%)		1/89 (1.1%)
Reflux oesophagitis	3/151 (2%)		1/89 (1.1%)
Stomatitis	3/151 (2%)		1/89 (1.1%)
Toothache	1/151 (0.7%)		1/89 (1.1%)
Vomiting	1/151 (0.7%)		1/89 (1.1%)
Gastroduodenitis	1/151 (0.7%)		0/89 (0%)
General disorders
Chest discomfort	1/151 (0.7%)		1/89 (1.1%)
Chest pain	1/151 (0.7%)		0/89 (0%)
Malaise	1/151 (0.7%)		1/89 (1.1%)
Oedema peripheral	0/151 (0%)		1/89 (1.1%)
Pain	1/151 (0.7%)		0/89 (0%)
Pyrexia	0/151 (0%)		1/89 (1.1%)
Vaccination site dermatitis	1/151 (0.7%)		0/89 (0%)
Hepatobiliary disorders
Hepatic function abnormal	1/151 (0.7%)		0/89 (0%)
Hepatic steatosis	2/151 (1.3%)		1/89 (1.1%)
Hyperplastic cholecystopathy	1/151 (0.7%)		0/89 (0%)
Gallbladder polyp	2/151 (1.3%)		0/89 (0%)
Immune system disorders
Seasonal allergy	0/151 (0%)		2/89 (2.2%)
Infections and infestations
Acute tonsillitis	0/151 (0%)		1/89 (1.1%)
Bronchitis	9/151 (6%)		8/89 (9%)
Cellulitis	1/151 (0.7%)		1/89 (1.1%)
Chronic sinusitis	1/151 (0.7%)		0/89 (0%)
Cystitis	3/151 (2%)		2/89 (2.2%)
Dermatitis infected	0/151 (0%)		1/89 (1.1%)
Folliculitis	0/151 (0%)		1/89 (1.1%)
Gastroenteritis	3/151 (2%)		1/89 (1.1%)
Herpes zoster	2/151 (1.3%)		1/89 (1.1%)
Hordeolum	0/151 (0%)		2/89 (2.2%)
Influenza	1/151 (0.7%)		1/89 (1.1%)
Laryngitis	1/151 (0.7%)		0/89 (0%)
Nasopharyngitis	56/151 (37.1%)		29/89 (32.6%)
Onychomycosis	5/151 (3.3%)		1/89 (1.1%)
Otitis media	1/151 (0.7%)		0/89 (0%)
Otitis media chronic	1/151 (0.7%)		0/89 (0%)
Pharyngitis	8/151 (5.3%)		4/89 (4.5%)
Pulpitis dental	0/151 (0%)		1/89 (1.1%)
Rhinitis	0/151 (0%)		1/89 (1.1%)
Tinea pedis	7/151 (4.6%)		2/89 (2.2%)
Tonsillitis	1/151 (0.7%)		0/89 (0%)
Vulvitis	1/151 (0.7%)		0/89 (0%)
Vulvovaginitis	1/151 (0.7%)		0/89 (0%)
Wound infection	1/151 (0.7%)		0/89 (0%)
Gastritis viral	0/151 (0%)		1/89 (1.1%)
Helicobacter infection	0/151 (0%)		1/89 (1.1%)
Myringitis	0/151 (0%)		1/89 (1.1%)
Enterocolitis viral	1/151 (0.7%)		0/89 (0%)
Cystitis bacterial	0/151 (0%)		1/89 (1.1%)
Oral herpes	2/151 (1.3%)		1/89 (1.1%)
Latent syphilis	1/151 (0.7%)		0/89 (0%)
Injury, poisoning and procedural complications
Arthropod sting	3/151 (2%)		1/89 (1.1%)
Chillblains	1/151 (0.7%)		0/89 (0%)
Foot fracture	1/151 (0.7%)		0/89 (0%)
Humerus fracture	0/151 (0%)		1/89 (1.1%)
Joint sprain	3/151 (2%)		1/89 (1.1%)
Muscle injury	1/151 (0.7%)		0/89 (0%)
Radius fracture	1/151 (0.7%)		1/89 (1.1%)
Ulna fracture	0/151 (0%)		1/89 (1.1%)
Wrist fracture	0/151 (0%)		1/89 (1.1%)
Excoriation	2/151 (1.3%)		1/89 (1.1%)
Contusion	9/151 (6%)		5/89 (5.6%)
Thermal burn	1/151 (0.7%)		0/89 (0%)
Skin laceration	0/151 (0%)		1/89 (1.1%)
Open wound	1/151 (0.7%)		2/89 (2.2%)
Heat illness	1/151 (0.7%)		1/89 (1.1%)
Investigations
Alanine aminotransferase increased	3/151 (2%)		3/89 (3.4%)
Albumin urine present	2/151 (1.3%)		0/89 (0%)
Aspartate aminotransferase increased	2/151 (1.3%)		3/89 (3.4%)
Blood creatine phosphokinase increased	14/151 (9.3%)		7/89 (7.9%)
Blood creatinine increased	0/151 (0%)		1/89 (1.1%)
Blood potassium increased	5/151 (3.3%)		3/89 (3.4%)
Blood triglycerides increased	3/151 (2%)		2/89 (2.2%)
Blood uric acid increased	4/151 (2.6%)		2/89 (2.2%)
Eosinophil count increased	1/151 (0.7%)		1/89 (1.1%)
Gamma-glutamyltransferase increased	5/151 (3.3%)		3/89 (3.4%)
Glucose urine present	9/151 (6%)		16/89 (18%)
Blood urine present	11/151 (7.3%)		5/89 (5.6%)
Monocyte count decreased	1/151 (0.7%)		0/89 (0%)
White blood cell count increased	1/151 (0.7%)		1/89 (1.1%)
Protein urine present	14/151 (9.3%)		13/89 (14.6%)
Urine ketone body present	2/151 (1.3%)		5/89 (5.6%)
Blood alkaline phosphatase increased	1/151 (0.7%)		1/89 (1.1%)
Occult blood positive	1/151 (0.7%)		0/89 (0%)
Metabolism and nutrition disorders
Gout	0/151 (0%)		1/89 (1.1%)
Hyperuricaemia	0/151 (0%)		1/89 (1.1%)
Hypoglycaemia	5/151 (3.3%)		9/89 (10.1%)
Decreased appetite	1/151 (0.7%)		0/89 (0%)
Hyperlipidaemia	1/151 (0.7%)		2/89 (2.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	11/151 (7.3%)		3/89 (3.4%)
Arthritis	1/151 (0.7%)		0/89 (0%)
Back pain	7/151 (4.6%)		2/89 (2.2%)
Fasciitis	0/151 (0%)		1/89 (1.1%)
Joint effusion	1/151 (0.7%)		0/89 (0%)
Lumbar spinal stenosis	1/151 (0.7%)		0/89 (0%)
Monarthritis	1/151 (0.7%)		0/89 (0%)
Muscle spasms	1/151 (0.7%)		1/89 (1.1%)
Musculoskeletal pain	1/151 (0.7%)		0/89 (0%)
Myalgia	2/151 (1.3%)		0/89 (0%)
Osteoarthritis	1/151 (0.7%)		6/89 (6.7%)
Osteoporosis	1/151 (0.7%)		0/89 (0%)
Pain in extremity	0/151 (0%)		1/89 (1.1%)
Periarthritis	3/151 (2%)		1/89 (1.1%)
Plantar fasciitis	1/151 (0.7%)		0/89 (0%)
Spinal osteoarthritis	3/151 (2%)		2/89 (2.2%)
Tenosynovitis	3/151 (2%)		0/89 (0%)
Trigger finger	1/151 (0.7%)		2/89 (2.2%)
Musculoskeletal stiffness	1/151 (0.7%)		3/89 (3.4%)
Tenosynovitis stenosans	0/151 (0%)		1/89 (1.1%)
Spinal ligament ossification	0/151 (0%)		1/89 (1.1%)
Spondylolisthesis	0/151 (0%)		1/89 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon	0/151 (0%)		1/89 (1.1%)
Skin papilloma	0/151 (0%)		1/89 (1.1%)
Uterine leiomyoma	1/151 (0.7%)		0/89 (0%)
Gastrointestinal neoplasm	2/151 (1.3%)		0/89 (0%)
Nervous system disorders
Cervicobrachial syndrome	1/151 (0.7%)		1/89 (1.1%)
Diabetic neuropathy	4/151 (2.6%)		0/89 (0%)
Dizziness	1/151 (0.7%)		1/89 (1.1%)
Dizziness postural	2/151 (1.3%)		0/89 (0%)
Headache	7/151 (4.6%)		0/89 (0%)
Migraine	1/151 (0.7%)		0/89 (0%)
Somnolence	1/151 (0.7%)		0/89 (0%)
Tension headache	0/151 (0%)		2/89 (2.2%)
Carotid arteriosclerosis	3/151 (2%)		0/89 (0%)
Occipital neuralgia	1/151 (0.7%)		0/89 (0%)
Psychiatric disorders
Anxiety	1/151 (0.7%)		0/89 (0%)
Depression	1/151 (0.7%)		0/89 (0%)
Insomnia	6/151 (4%)		9/89 (10.1%)
Schizophrenia	0/151 (0%)		1/89 (1.1%)
Somatoform disorder gastrointestinal	0/151 (0%)		1/89 (1.1%)
Anxiety disorder	1/151 (0.7%)		0/89 (0%)
Renal and urinary disorders
Hypertonic bladder	0/151 (0%)		1/89 (1.1%)
Nephrolithiasis	3/151 (2%)		0/89 (0%)
Pollakiuria	0/151 (0%)		1/89 (1.1%)
Urinary incontinence	1/151 (0.7%)		0/89 (0%)
Diabetic nephropathy	0/151 (0%)		1/89 (1.1%)
Pyelocaliectasis	0/151 (0%)		1/89 (1.1%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/151 (0.7%)		1/89 (1.1%)
Calculus prostatic	1/151 (0.7%)		0/89 (0%)
Dysmenorrhoea	1/151 (0.7%)		0/89 (0%)
Menstruation irregular	1/151 (0.7%)		0/89 (0%)
Prostatitis	2/151 (1.3%)		0/89 (0%)
Uterine prolapse	1/151 (0.7%)		0/89 (0%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/151 (0.7%)		0/89 (0%)
Cough	1/151 (0.7%)		0/89 (0%)
Rhinitis allergic	6/151 (4%)		0/89 (0%)
Sneezing	1/151 (0.7%)		0/89 (0%)
Upper respiratory tract inflammation	9/151 (6%)		10/89 (11.2%)
Laryngeal granuloma	1/151 (0.7%)		0/89 (0%)
Upper-airway cough syndrome	1/151 (0.7%)		0/89 (0%)
Skin and subcutaneous tissue disorders
Acne	1/151 (0.7%)		1/89 (1.1%)
Dermatitis	1/151 (0.7%)		0/89 (0%)
Dermatitis allergic	1/151 (0.7%)		0/89 (0%)
Dermatitis atopic	1/151 (0.7%)		1/89 (1.1%)
Dermatitis contact	3/151 (2%)		0/89 (0%)
Dry skin	1/151 (0.7%)		0/89 (0%)
Eczema	8/151 (5.3%)		3/89 (3.4%)
Eczema asteatotic	1/151 (0.7%)		1/89 (1.1%)
Haemorrhage subcutaneous	1/151 (0.7%)		0/89 (0%)
Heat rash	1/151 (0.7%)		1/89 (1.1%)
Hyperkeratosis	1/151 (0.7%)		0/89 (0%)
Papule	1/151 (0.7%)		0/89 (0%)
Pruritus	3/151 (2%)		0/89 (0%)
Pustular psoriasis	1/151 (0.7%)		0/89 (0%)
Rash	4/151 (2.6%)		1/89 (1.1%)
Rash generalised	1/151 (0.7%)		0/89 (0%)
Seborrhoeic dermatitis	1/151 (0.7%)		0/89 (0%)
Skin nodule	1/151 (0.7%)		0/89 (0%)
Urticaria	0/151 (0%)		1/89 (1.1%)
Xeroderma	1/151 (0.7%)		0/89 (0%)
Pruritus generalised	0/151 (0%)		1/89 (1.1%)
Vascular disorders
Hypertension	8/151 (5.3%)		0/89 (0%)
Orthostatic hypotension	1/151 (0.7%)		0/89 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.