Trial Outcomes & Findings for Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive (NCT NCT02792504)
NCT ID: NCT02792504
Last Updated: 2021-08-05
Results Overview
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. AEs included both serious and all non-serious adverse events.
COMPLETED
669 participants
Baseline up to 28 days after last dose of study drug (up to 22 months)
2021-08-05
Participant Flow
This observational study was conducted in Korea. Enrolled participants included were administered with Duavive tablet 0.45 milligram (mg)/20 mg (conjugated estrogens 0.45 mg, bazedoxifene acetate 20 mg) for the first time as a part of routine treatment after the start of the study at a study site and complied with the local labeling. Participants were planned to be evaluated for 3 months, 6 months or more depending upon till when Duavive tablet was administered based on investigator's judgement.
In this study no screening was performed. Women participants who were administered Duavive tablet were enrolled.
Participant milestones
| Measure |
Duavive
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Overall Study
STARTED
|
669
|
|
Overall Study
Safety Analysis Set
|
639
|
|
Overall Study
Efficacy Analysis Set
|
390
|
|
Overall Study
COMPLETED
|
639
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Duavive
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
24
|
|
Overall Study
Violated inclusion/exclusion criteria
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Duavive
n=639 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Age, Continuous
|
53.65 years
STANDARD_DEVIATION 5.59 • n=639 Participants
|
|
Sex: Female, Male
Female
|
639 Participants
n=639 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=639 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days after last dose of study drug (up to 22 months)Population: Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. AEs included both serious and all non-serious adverse events.
Outcome measures
| Measure |
Duavive
n=639 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
73 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days after last dose of study drug (up to 22 months)Population: Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. A treatment-related adverse event was any untoward medical occurrence attributed to Duavive tablet in a participant who received Duavive tablet. 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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Duavive tablet was assessed by the investigator.
Outcome measures
| Measure |
Duavive
n=639 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment Related AEs
|
58 Participants
|
|
Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment Related SAEs
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days after last dose of study drug (up to 22 months)Population: Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up. Here, "Overall Number of Participants Analyzed" signifies number of participants with adverse events.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Following measures were taken for AEs in relation to Duavive tablet: no change in treatment, permanently discontinued treatment and temporarily discontinued treatment.
Outcome measures
| Measure |
Duavive
n=73 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Number of Participants Classified According to Measures Taken for Adverse Events
No change in treatment
|
19 Participants
|
|
Number of Participants Classified According to Measures Taken for Adverse Events
Permanently discontinued treatment
|
53 Participants
|
|
Number of Participants Classified According to Measures Taken for Adverse Events
Temporarily discontinued treatment
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Efficacy analysis set (EAS) of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure at Month 3.
Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated.
Outcome measures
| Measure |
Duavive
n=387 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3
Effectiveness
|
319 Participants
|
|
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3
Ineffectiveness
|
68 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: EAS of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure at Month 6.
Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated.
Outcome measures
| Measure |
Duavive
n=141 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6
Effectiveness
|
118 Participants
|
|
Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6
Ineffectiveness
|
23 Participants
|
PRIMARY outcome
Timeframe: Baseline, Last visit (last visit was anytime up to a maximum of Month 21)Population: EAS of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause.
Improvement from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved.
Outcome measures
| Measure |
Duavive
n=390 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit
|
82.31 percentage of participants
Interval 78.15 to 85.97
|
PRIMARY outcome
Timeframe: Month 3Population: EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis.
Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.
Outcome measures
| Measure |
Duavive
n=22 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3
|
17 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis. Here, "Overall number of participants analyzed" = participants who were administered with Duavive tablet for prevention of postmenopausal osteoporosis at Month 6.
Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.
Outcome measures
| Measure |
Duavive
n=1 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6
|
1 Participants
|
PRIMARY outcome
Timeframe: Last visit (last visit was anytime up to a maximum of Month 21)Population: EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis.
Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported.
Outcome measures
| Measure |
Duavive
n=22 Participants
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit
|
77.27 percentage of participants
Interval 54.63 to 92.18
|
Adverse Events
Duavive
Serious adverse events
| Measure |
Duavive
n=639 participants at risk
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Ear and labyrinth disorders
Meniere's disease
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
Other adverse events
| Measure |
Duavive
n=639 participants at risk
Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.
|
|---|---|
|
Vascular disorders
Flushing
|
0.94%
6/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.47%
3/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Cardiac disorders
Palpitations
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Endocrine disorders
Hypothyroidism
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Dry mouth
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastritis
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.47%
3/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
General disorders
Chest pain
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
General disorders
Drug ineffective
|
1.9%
12/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
General disorders
Face oedema
|
0.47%
3/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
General disorders
Fatigue
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
General disorders
Oedema peripheral
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
General disorders
Pain
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
General disorders
Pyrexia
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Hepatobiliary disorders
Hepatitis
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Infections and infestations
Genital herpes
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Investigations
Alanine aminotransferase increased
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Investigations
Weight increased
|
0.63%
4/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Nervous system disorders
Dizziness
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Nervous system disorders
Headache
|
0.78%
5/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Nervous system disorders
Paraesthesia
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Nervous system disorders
Restless legs syndrome
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Psychiatric disorders
Insomnia
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Psychiatric disorders
Mood altered
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Reproductive system and breast disorders
Breast pain
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.31%
2/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.16%
1/639 • Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
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