Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01793142
• Collaborator: (none)
• Enrollment: 3,430
• Locations: 60
• Actual Duration (Months): 43.2
• Patients Per Site: 57.2
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for New Drugs

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Viviant

Detailed Description

continuous enrollment

Study Design

• Study Type: Observational
• Actual Enrollment: 3430 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.
• Actual Study Start Date: Oct 24, 2013
• Actual Primary Completion Date: May 31, 2017
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Viviant treatment group Viviant treatment group	Drug: Viviant; Viviant (Bazedoxifene) 20mg once daily

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

2. Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs [Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)]

   An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.

Secondary Outcome Measures

1. Overall Efficacy Evaluation of Viviant 20 mg Tablet [Baseline up to 3 months]

   Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.

2. Number of Participants With Osteoporosis Related Fractures [Baseline up to 3 months]

3. Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA) [Baseline up to 3 months]

   DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.

4. Number of Participants With Abnormal X-ray Result [Baseline up to 3 months]

   Criteria for abnormality was based on investigator's discretion.

5. Number of Participants With Abnormal Bone Mineral Density Result [Baseline up to 3 months]

   A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.

6. Number of Participants With Abnormal Biochemical Markers of Bone Turnover [Baseline up to 3 months]

   In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Postmenopausal osteoporosis and osteopenia patients

Exclusion Criteria:

• Patients with active or past history of venous thromboembolic events including deep vein thrombosis,

• Patients with pulmonary embolism and retinal vein thrombosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Haeundae Paik Hospital	Haeundae-gu	Busan	Korea, Republic of	48108
2	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul	Capital Metropolitan	Korea, Republic of	06591
3	Dankook University Hospital	Cheonan-si	Chuncheongnam-do	Korea, Republic of	31116
4	Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital	Wonju-Si	Gangwon-do	Korea, Republic of	26426
5	Dongguk University Gyeongju Hospital	Gyeongju-si	Gyeongbuk	Korea, Republic of	780-350
6	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do	Korea, Republic of	14068
7	Soon Chun Hyang University Bucheon Hospital	Bucheon-Si	Gyeonggi-do	Korea, Republic of	14584
8	Sejong Hospital	Bucheon-Si	Gyeonggi-do	Korea, Republic of	422-807
9	Dongguk University Ilsan Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10326
10	National Health Insurance Corporation Ilsan Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10444
11	Myongji Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10475
12	Il-San Gaspel Hospital	Goyang-Si	Gyeonggi-do	Korea, Republic of	410-831
13	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	411-706
14	Inje University Ilsanpaik Hospital	Goyang	Gyeonggi-do	Korea, Republic of	10380
15	Wonkwang University Sanbon Hospital	Gunpo-si	Gyeonggi-do	Korea, Republic of	15865
16	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do	Korea, Republic of	11923
17	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
18	St. Vincent's Hospital-The Catholic University of Korea	Suwon-si	Gyeonggi-do	Korea, Republic of	16247
19	Ajou University Hospital	Suwon-si	Gyeonggi-do	Korea, Republic of	16499
20	Gyeongsang National University Hospital	Jinju-si	Gyeongsangnam-do	Korea, Republic of	52727
21	Yangsan Hospital-Pusan National University	Yangsan-si	Gyeongsangnam-do	Korea, Republic of	50612
22	Wonkwang University Hospital	Iksan-si	Jeollabuk-do	Korea, Republic of	54538
23	Soon Chun Hyang University Hospital Seoul	Seoul	Korea	Korea, Republic of	04401
24	Eulji University Hospital	Daejeon	Republic OF Korea	Korea, Republic of	35233
25	Severance Hospital, Yonsei University Health System	Seoul	Seodaemun-gu	Korea, Republic of	03722
26	Sung Mo O.S	Daebang-dong	Seoul	Korea, Republic of	156-808
27	Hanyang University Medical Center	Seongdong-ku	Seoul	Korea, Republic of	133-792
28	Pusan National University Hospital	Busan		Korea, Republic of	49241
29	Dongrae Bongseng Hospital	Busan		Korea, Republic of	607-712
30	Centum Hospital	Busan		Korea, Republic of	613-812
31	Keimyung University Dongsan Hospital	Daegu		Korea, Republic of	41931
32	Kyungpook National Univ. Hospital	Daegu		Korea, Republic of	700-721
33	Daejeon St. Mary's Hospital-The Catholic University of Korea	Daejeon		Korea, Republic of	34943
34	Chungnam National University Hospital (CNUH)	Daejeon		Korea, Republic of	35015
35	Wonju Severance Christian Hospital	Gangwon-do		Korea, Republic of	220-701
36	Hosan OS Clinic	Goyang-si		Korea, Republic of	412-821
37	Gwangju Veterans Hosptial	Gwangju-si		Korea, Republic of	62284
38	Donguk University Gyeongju Hospital	Gyoungju		Korea, Republic of	780-350
39	Gachon University Gil Hospital	Incheon		Korea, Republic of	21565
40	Christian Internal Medicine Clinic	Incheon		Korea, Republic of	22104
41	Inje University Sanggye Paik Hospital	Seoul		Korea, Republic of	01757
42	Kyung Hee University Hospital	Seoul		Korea, Republic of	02447
43	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
44	Seoul National University Hospital	Seoul		Korea, Republic of	03080
45	Severance Hospital, Yeonsei University Health System	Seoul		Korea, Republic of	03722
46	Severance Hospital-Yonsei University College of Medicine	Seoul		Korea, Republic of	03722
47	Cheil General Hospital & Women's Healthcare Center	Seoul		Korea, Republic of	04619
48	Hanyang University Seoul Hospital	Seoul		Korea, Republic of	04763
49	Konkuk University Medical Center	Seoul		Korea, Republic of	05030
50	Asan Medical Center-University of Ulsan College of Medicine	Seoul		Korea, Republic of	05505
51	Asan Medical Center	Seoul		Korea, Republic of	05505
52	Seoul St. Mary Hospital, The Catholic University of Korea	Seoul		Korea, Republic of	06591
53	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
54	Chung-Ang University Hospital	Seoul		Korea, Republic of	06973
55	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of	07061
56	Choongmu Hospital	Seoul		Korea, Republic of	07301
57	Seoul Medical Center	Seoul		Korea, Republic of	131-865
58	Kwangmyeong Sungae Hospital	Seoul		Korea, Republic of	14241
59	Hongik Hospital	Seoul		Korea, Republic of
60	Jung Dong Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 22, 2016

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01793142
• Other Study ID Numbers: B1781047
• First Posted: Feb 15, 2013
• Last Update Posted: Dec 24, 2018
• Last Verified: May 1, 2018

• Keywords provided by Pfizer: Osteoporosis; postmenopausal; SERM
• Additional relevant MeSH terms: Osteoporosis

Study Results

Participant Flow

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Period Title: Overall Study
STARTED	3430
Treated	3423
COMPLETED	3423
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Overall Participants	3423
Age (years) [Mean (Standard Deviation) ]
Mean Age	69.51 (10.03)
Sex: Female, Male (Count of Participants)
Female	3423 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Weight Continuous (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	55.12 (8.26)
Height Continuous (centimeter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter]	153.56 (5.87)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Time Frame	Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Measure Participants	3423
AEs	209 6.1%
SAEs	17 0.5%

2. Secondary Outcome

Title	Overall Efficacy Evaluation of Viviant 20 mg Tablet
Description	Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.
Time Frame	Baseline up to 3 months

Outcome Measure Data

Analysis Population Description

Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once.

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Measure Participants	3111
Improved	1283 37.5%
No change	1814 53%
Worsened	14 0.4%
Unevaluable	0 0%

3. Secondary Outcome

Title	Number of Participants With Osteoporosis Related Fractures
Time Frame	Baseline up to 3 months

Outcome Measure Data

Analysis Population Description

Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once.

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Measure Participants	3111
Count of Participants [Participants]	4 0.1%

4. Secondary Outcome

Title	Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)
Description	DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
Time Frame	Baseline up to 3 months

Outcome Measure Data

Analysis Population Description

Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, "N (number of participants analyzed)" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Measure Participants	62
Count of Participants [Participants]	7 0.2%

5. Primary Outcome

Title	Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs
Description	An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.
Time Frame	Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Measure Participants	3423
ADRs	132 3.9%
Serious ADRs	3 0.1%
Unexpected ADRs	93 2.7%

6. Secondary Outcome

Title	Number of Participants With Abnormal X-ray Result
Description	Criteria for abnormality was based on investigator's discretion.
Time Frame	Baseline up to 3 months

Outcome Measure Data

Analysis Population Description

Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Measure Participants	40
Count of Participants [Participants]	0 0%

7. Secondary Outcome

Title	Number of Participants With Abnormal Bone Mineral Density Result
Description	A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
Time Frame	Baseline up to 3 months

Outcome Measure Data

Analysis Population Description

Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Measure Participants	1
Count of Participants [Participants]	0 0%

8. Secondary Outcome

Title	Number of Participants With Abnormal Biochemical Markers of Bone Turnover
Description	In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.
Time Frame	Baseline up to 3 months

Outcome Measure Data

Analysis Population Description

Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, "n (number analyzed)" signifies the number of participants with available data for each category.

Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
Measure Participants	3111
CTX	0 0%
Osteocalcin	0 0%
Bone specific alkaline phosphatase	0 0%

Adverse Events

Time Frame	Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Arm/Group Title	Viviant Tablet 20 mg
Arm/Group Description	Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.
All Cause Mortality
	Viviant Tablet 20 mg
	Affected / at Risk (%)	# Events
Total	1/3423 (0%)
Serious Adverse Events
	Viviant Tablet 20 mg
	Affected / at Risk (%)	# Events
Total	17/3423 (0.5%)
Cardiac disorders
BRADYCARDIA	1/3423 (0%)
Gastrointestinal disorders
ABDOMINAL PAIN	1/3423 (0%)
General disorders
DEATH	1/3423 (0%)
FATIGUE	1/3423 (0%)
FEVER	1/3423 (0%)
OEDEMA GENERALISED	1/3423 (0%)
Hepatobiliary disorders
Bile duct stone	1/3423 (0%)
Infections and infestations
PYELONEPHRITIS	3/3423 (0.1%)
Musculoskeletal and connective tissue disorders
FRACTURE	2/3423 (0.1%)
MYALGIA	1/3423 (0%)
ROTARY CUFF SYNDROME	1/3423 (0%)
Nervous system disorders
SPINAL STENOSIS	1/3423 (0%)
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INSUFFICIENCY	1/3423 (0%)
Vascular disorders
CEREBRAL HAEMORRHAGE	1/3423 (0%)
CEREBRAL INFARCTION	2/3423 (0.1%)
Other (Not Including Serious) Adverse Events
	Viviant Tablet 20 mg
	Affected / at Risk (%)	# Events
Total	192/3423 (5.6%)
Blood and lymphatic system disorders
LEUKOCYTOSIS	1/3423 (0%)
Cardiac disorders
PALPITATION	5/3423 (0.1%)
Eye disorders
EYE PAIN	2/3423 (0.1%)
RETINAL HAEMORRHAGE	1/3423 (0%)
VISION ABNORMAL	4/3423 (0.1%)
Gastrointestinal disorders
ABDOMINAL PAIN	7/3423 (0.2%)
COLONIC POLYP	2/3423 (0.1%)
CONSTIPATION	4/3423 (0.1%)
DIARRHOEA	4/3423 (0.1%)
DYSPEPSIA	51/3423 (1.5%)
ERUCTATION	1/3423 (0%)
GASTRITIS	3/3423 (0.1%)
MOUTH DRY	8/3423 (0.2%)
NAUSEA	13/3423 (0.4%)
VOMITING	3/3423 (0.1%)
General disorders
ALLERGIC REACTION	1/3423 (0%)
ASTHENIA	1/3423 (0%)
CHEST DISCOMFORT	2/3423 (0.1%)
EFFECT, LACK OF	1/3423 (0%)
FACE OEDEMA	2/3423 (0.1%)
FEVER	2/3423 (0.1%)
LEG PAIN	3/3423 (0.1%)
MALAISE	1/3423 (0%)
OEDEMA	2/3423 (0.1%)
OEDEMA GENERALISED	2/3423 (0.1%)
OEDEMA PERIORBITAL	1/3423 (0%)
OEDEMA PERIPHERAL	6/3423 (0.2%)
TEMPERATURE CHANGED SENSATION	2/3423 (0.1%)
Hepatobiliary disorders
HEPATIC CYST	1/3423 (0%)
HEPATOCELLULAR DAMAGE	1/3423 (0%)
PHOSPHATASE ALKALINE INCREASED	2/3423 (0.1%)
SGOT INCREASED	1/3423 (0%)
SGPT INCREASED	1/3423 (0%)
Infections and infestations
BRONCHITIS	1/3423 (0%)
CYSTITIS	1/3423 (0%)
PHARYNGITIS	6/3423 (0.2%)
PNEUMONIA	1/3423 (0%)
PYELONEPHRITIS	1/3423 (0%)
UPPER RESPIRATORY TRACT INFECTION	1/3423 (0%)
Injury, poisoning and procedural complications
Contusion	1/3423 (0%)
LACERATION	1/3423 (0%)
Metabolism and nutrition disorders
HYPERLIPAEMIA	1/3423 (0%)
OBESITY CENTRAL	1/3423 (0%)
WEIGHT INCREASE	2/3423 (0.1%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	2/3423 (0.1%)
BACK PAIN	3/3423 (0.1%)
FRACTURE	2/3423 (0.1%)
MUSCLE WEAKNESS	1/3423 (0%)
MYALGIA	6/3423 (0.2%)
Nervous system disorders
CRAMPS LEGS	3/3423 (0.1%)
DIZZINESS	5/3423 (0.1%)
DIZZINESS POSTURAL	1/3423 (0%)
HEADACHE	6/3423 (0.2%)
SPINAL STENOSIS	1/3423 (0%)
Psychiatric disorders
INSOMNIA	3/3423 (0.1%)
Renal and urinary disorders
DYSURIA	1/3423 (0%)
RENAL CYST	1/3423 (0%)
URINARY INCONTINENCE	1/3423 (0%)
URINE ABNORMAL	1/3423 (0%)
Reproductive system and breast disorders
BREAST ENGORGEMENT	1/3423 (0%)
VAGINAL HAEMORRHAGE	2/3423 (0.1%)
Respiratory, thoracic and mediastinal disorders
ASTHMA	1/3423 (0%)
COUGHING	1/3423 (0%)
DYSPNOEA	1/3423 (0%)
LARYNGITIS	1/3423 (0%)
PLEURAL EFFUSION	1/3423 (0%)
SPUTUM DISORDER	1/3423 (0%)
Skin and subcutaneous tissue disorders
ALOPECIA	1/3423 (0%)
DERMATITIS	2/3423 (0.1%)
ECZEMA	1/3423 (0%)
PRURITUS	8/3423 (0.2%)
RASH	5/3423 (0.1%)
SKIN REACTION LOCALISED	1/3423 (0%)
SWEATING INCREASED	1/3423 (0%)
URTICARIA	5/3423 (0.1%)
Vascular disorders
FLUSHING	13/3423 (0.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.