Trial Outcomes & Findings for Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan) (NCT NCT01470326)
NCT ID: NCT01470326
Last Updated: 2018-11-05
Results Overview
Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included "fracture" in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1.
Recruitment status
COMPLETED
Target enrollment
3187 participants
Primary outcome timeframe
3 years
Results posted on
2018-11-05
Participant Flow
Participant milestones
| Measure |
Viviant (Bazedoxifene Acetate)
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Overall Study
STARTED
|
3187
|
|
Overall Study
COMPLETED
|
3034
|
|
Overall Study
NOT COMPLETED
|
153
|
Reasons for withdrawal
| Measure |
Viviant (Bazedoxifene Acetate)
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Overall Study
Protocol Violation
|
32
|
|
Overall Study
No Drug Administration Information
|
2
|
|
Overall Study
No Visit After 1st Day of Treatment
|
119
|
Baseline Characteristics
Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Baseline characteristics by cohort
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Age, Customized
<15 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
≥15 and <65 years
|
514 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
2520 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3034 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Smoking Status
Smoker
|
94 Participants
n=5 Participants
|
|
Smoking Status
Non-Smoker
|
2211 Participants
n=5 Participants
|
|
Smoking Status
Unknown
|
729 Participants
n=5 Participants
|
|
Use of Steroid
Yes
|
101 Participants
n=5 Participants
|
|
Use of Steroid
No
|
2523 Participants
n=5 Participants
|
|
Use of Steroid
Unknown
|
410 Participants
n=5 Participants
|
|
Use of Previous Medication
Yes
|
1271 Participants
n=5 Participants
|
|
Use of Previous Medication
No
|
1647 Participants
n=5 Participants
|
|
Use of Previous Medication
Unknown
|
116 Participants
n=5 Participants
|
|
Use of Concomitant Medication
Yes
|
2103 Participants
n=5 Participants
|
|
Use of Concomitant Medication
No
|
931 Participants
n=5 Participants
|
|
Fracture History
Yes
|
842 Participants
n=5 Participants
|
|
Fracture History
No
|
1807 Participants
n=5 Participants
|
|
Fracture History
Unknown
|
385 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician.
Outcome measures
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events
Treatment-related Adverse Event
|
137 Participants
|
|
Number of Participants With Treatment-Related Adverse Events
Treatment-related Serious Adverse Event
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The effectiveness analysis set was identical with the safety analysis set which comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included "fracture" in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1.
Outcome measures
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Number of Participants With Any Fracture
|
53 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician.
Outcome measures
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
|
80 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Outcome measures
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events by Age
≥15 and <65 years
|
25 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Age
≥65 years
|
112 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Outcome measures
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events by Smoking Status
Smoker
|
0 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Smoking Status
Non-Smonker
|
85 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Smoking Status
Unknown
|
52 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Outcome measures
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events by Use of Steroid
Yes
|
13 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Use of Steroid
No
|
99 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Use of Steroid
Unknown
|
25 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.
Outcome measures
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication
Yes
|
66 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication
No
|
64 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication
Unknown
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.
Outcome measures
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 Participants
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication
Yes
|
101 Participants
|
|
Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication
No
|
36 Participants
|
Adverse Events
Viviant (Bazedoxifene Acetate)
Serious events: 95 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 participants at risk
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Infections and infestations
Biliary tract infection
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
4/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
8/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm recurrence
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Nervous system disorders
Cerebellar infarction
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.16%
5/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.13%
4/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.13%
4/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
4/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
3/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
General disorders
Condition aggravated
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
General disorders
Death
|
0.13%
4/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
General disorders
Disease progression
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Investigations
Haemoglobin decreased
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.10%
3/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.16%
5/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.16%
5/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.16%
5/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.03%
1/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.07%
2/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
Other adverse events
| Measure |
Viviant (Bazedoxifene Acetate)
n=3034 participants at risk
Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.82%
25/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.59%
18/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.66%
20/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.66%
20/3034
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER