Trial Outcomes & Findings for Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice (NCT NCT01793142)
NCT ID: NCT01793142
Last Updated: 2018-12-24
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
3430 participants
Primary outcome timeframe
Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)
Results posted on
2018-12-24
Participant Flow
Participant milestones
| Measure |
Viviant Tablet 20 mg
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.
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|---|---|
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Overall Study
STARTED
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3430
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Overall Study
Treated
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3423
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Overall Study
COMPLETED
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3423
|
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
| Measure |
Viviant Tablet 20 mg
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.
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Overall Study
Randomized not treated
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7
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Viviant Tablet 20 mg
n=3423 Participants
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.
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Age, Continuous
Mean Age
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69.51 years
STANDARD_DEVIATION 10.03 • n=3423 Participants
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Sex: Female, Male
Female
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3423 Participants
n=3423 Participants
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Sex: Female, Male
Male
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0 Participants
n=3423 Participants
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Weight Continuous
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55.12 kilograms
STANDARD_DEVIATION 8.26 • n=3423 Participants
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Height Continuous
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153.56 centimeter
STANDARD_DEVIATION 5.87 • n=3423 Participants
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PRIMARY outcome
Timeframe: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)Population: Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.
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.
Outcome measures
| Measure |
Viviant Tablet 20 mg
n=3423 Participants
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.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
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209 Participants
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
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17 Participants
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PRIMARY outcome
Timeframe: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)Population: Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.
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.
Outcome measures
| Measure |
Viviant Tablet 20 mg
n=3423 Participants
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.
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Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs
ADRs
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132 Participants
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Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs
Serious ADRs
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3 Participants
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Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs
Unexpected ADRs
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93 Participants
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SECONDARY outcome
Timeframe: Baseline up to 3 monthsPopulation: Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once.
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.
Outcome measures
| Measure |
Viviant Tablet 20 mg
n=3111 Participants
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.
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Overall Efficacy Evaluation of Viviant 20 mg Tablet
Worsened
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14 Participants
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Overall Efficacy Evaluation of Viviant 20 mg Tablet
Improved
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1283 Participants
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Overall Efficacy Evaluation of Viviant 20 mg Tablet
No change
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1814 Participants
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Overall Efficacy Evaluation of Viviant 20 mg Tablet
Unevaluable
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0 Participants
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SECONDARY outcome
Timeframe: Baseline up to 3 monthsPopulation: Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once.
Outcome measures
| Measure |
Viviant Tablet 20 mg
n=3111 Participants
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.
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Number of Participants With Osteoporosis Related Fractures
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4 Participants
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SECONDARY outcome
Timeframe: Baseline up to 3 monthsPopulation: 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.
DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
Outcome measures
| Measure |
Viviant Tablet 20 mg
n=62 Participants
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.
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Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)
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7 Participants
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SECONDARY outcome
Timeframe: Baseline up to 3 monthsPopulation: 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.
Criteria for abnormality was based on investigator's discretion.
Outcome measures
| Measure |
Viviant Tablet 20 mg
n=40 Participants
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.
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Number of Participants With Abnormal X-ray Result
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0 Participants
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SECONDARY outcome
Timeframe: Baseline up to 3 monthsPopulation: 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.
A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
Outcome measures
| Measure |
Viviant Tablet 20 mg
n=1 Participants
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.
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Number of Participants With Abnormal Bone Mineral Density Result
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0 Participants
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SECONDARY outcome
Timeframe: Baseline up to 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Viviant Tablet 20 mg
n=3111 Participants
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.
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Number of Participants With Abnormal Biochemical Markers of Bone Turnover
CTX
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0 Participants
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Number of Participants With Abnormal Biochemical Markers of Bone Turnover
Osteocalcin
|
0 Participants
|
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Number of Participants With Abnormal Biochemical Markers of Bone Turnover
Bone specific alkaline phosphatase
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0 Participants
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Adverse Events
Viviant Tablet 20 mg
Serious events: 17 serious events
Other events: 192 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Viviant Tablet 20 mg
n=3423 participants at risk
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.
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Nervous system disorders
SPINAL STENOSIS
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0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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Cardiac disorders
BRADYCARDIA
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0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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Gastrointestinal disorders
ABDOMINAL PAIN
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0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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General disorders
DEATH
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0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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General disorders
FATIGUE
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0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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General disorders
FEVER
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0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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General disorders
OEDEMA GENERALISED
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0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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Hepatobiliary disorders
Bile duct stone
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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Infections and infestations
PYELONEPHRITIS
|
0.09%
3/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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Musculoskeletal and connective tissue disorders
FRACTURE
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
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Musculoskeletal and connective tissue disorders
ROTARY CUFF SYNDROME
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INSUFFICIENCY
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Vascular disorders
CEREBRAL HAEMORRHAGE
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Vascular disorders
CEREBRAL INFARCTION
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
Other adverse events
| Measure |
Viviant Tablet 20 mg
n=3423 participants at risk
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.
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|---|---|
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Psychiatric disorders
INSOMNIA
|
0.09%
3/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Nervous system disorders
CRAMPS LEGS
|
0.09%
3/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Nervous system disorders
DIZZINESS
|
0.15%
5/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Nervous system disorders
HEADACHE
|
0.18%
6/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Nervous system disorders
SPINAL STENOSIS
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Cardiac disorders
PALPITATION
|
0.15%
5/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Eye disorders
EYE PAIN
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Eye disorders
VISION ABNORMAL
|
0.12%
4/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.20%
7/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.12%
4/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.12%
4/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.5%
51/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
ERUCTATION
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.09%
3/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
MOUTH DRY
|
0.23%
8/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
NAUSEA
|
0.38%
13/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Gastrointestinal disorders
VOMITING
|
0.09%
3/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
ALLERGIC REACTION
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
ASTHENIA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
CHEST DISCOMFORT
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
EFFECT, LACK OF
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
FACE OEDEMA
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
FEVER
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
LEG PAIN
|
0.09%
3/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
MALAISE
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
OEDEMA
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
OEDEMA GENERALISED
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
OEDEMA PERIORBITAL
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.18%
6/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
General disorders
TEMPERATURE CHANGED SENSATION
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Hepatobiliary disorders
HEPATIC CYST
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Hepatobiliary disorders
HEPATOCELLULAR DAMAGE
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Hepatobiliary disorders
PHOSPHATASE ALKALINE INCREASED
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Hepatobiliary disorders
SGOT INCREASED
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Hepatobiliary disorders
SGPT INCREASED
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Infections and infestations
BRONCHITIS
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Infections and infestations
CYSTITIS
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Infections and infestations
PHARYNGITIS
|
0.18%
6/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Infections and infestations
PNEUMONIA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Metabolism and nutrition disorders
HYPERLIPAEMIA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Metabolism and nutrition disorders
OBESITY CENTRAL
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Metabolism and nutrition disorders
WEIGHT INCREASE
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.09%
3/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.18%
6/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Renal and urinary disorders
DYSURIA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Renal and urinary disorders
RENAL CYST
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Renal and urinary disorders
URINE ABNORMAL
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Reproductive system and breast disorders
BREAST ENGORGEMENT
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
COUGHING
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGITIS
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM DISORDER
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.06%
2/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.23%
8/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.15%
5/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION LOCALISED
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Skin and subcutaneous tissue disorders
SWEATING INCREASED
|
0.03%
1/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.15%
5/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
|
Vascular disorders
FLUSHING
|
0.38%
13/3423 • Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
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.
|
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