Trial Outcomes & Findings for Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS (NCT NCT02926911)
NCT ID: NCT02926911
Last Updated: 2026-01-27
Results Overview
To compare the number of patients that develop ipsilateral invasive cancer that received surgery to the number of patients that were placed on active monitoring after 2 years of follow-up
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
997 participants
Primary outcome timeframe
At 2 years follow-up
Results posted on
2026-01-27
Participant Flow
Participant milestones
| Measure |
Active Monitoring
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression) \>
\> Active Monitoring: Choice for endocrine therapy
|
Surgery
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease) \>
\> Surgery: Surgery +/- radiation choice for endocrine therapy
|
|---|---|---|
|
Overall Study
STARTED
|
497
|
498
|
|
Overall Study
COMPLETED
|
484
|
473
|
|
Overall Study
NOT COMPLETED
|
13
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some patients' receptor status was not collected
Baseline characteristics by cohort
| Measure |
Active Monitoring
n=484 Participants
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)\>
\> Active Monitoring: Choice for endocrine therapy
|
Surgery
n=473 Participants
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)\>
\> Surgery: Surgery +/- radiation choice for endocrine therapy
|
Total
n=957 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<55
|
112 Participants
n=484 Participants
|
114 Participants
n=473 Participants
|
226 Participants
n=957 Participants
|
|
Age, Customized
55-65
|
164 Participants
n=484 Participants
|
164 Participants
n=473 Participants
|
328 Participants
n=957 Participants
|
|
Age, Customized
>65
|
208 Participants
n=484 Participants
|
195 Participants
n=473 Participants
|
403 Participants
n=957 Participants
|
|
Sex: Female, Male
Female
|
484 Participants
n=484 Participants
|
473 Participants
n=473 Participants
|
957 Participants
n=957 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=484 Participants
|
0 Participants
n=473 Participants
|
0 Participants
n=957 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=484 Participants
|
17 Participants
n=473 Participants
|
51 Participants
n=957 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
438 Participants
n=484 Participants
|
440 Participants
n=473 Participants
|
878 Participants
n=957 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=484 Participants
|
16 Participants
n=473 Participants
|
28 Participants
n=957 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=484 Participants
|
1 Participants
n=473 Participants
|
2 Participants
n=957 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=484 Participants
|
23 Participants
n=473 Participants
|
46 Participants
n=957 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=484 Participants
|
3 Participants
n=473 Participants
|
3 Participants
n=957 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=484 Participants
|
70 Participants
n=473 Participants
|
150 Participants
n=957 Participants
|
|
Race (NIH/OMB)
White
|
359 Participants
n=484 Participants
|
359 Participants
n=473 Participants
|
718 Participants
n=957 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=484 Participants
|
2 Participants
n=473 Participants
|
5 Participants
n=957 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=484 Participants
|
15 Participants
n=473 Participants
|
33 Participants
n=957 Participants
|
|
DCIS laterality at diagnosis
Left
|
247 Participants
n=484 Participants
|
235 Participants
n=473 Participants
|
482 Participants
n=957 Participants
|
|
DCIS laterality at diagnosis
Right
|
233 Participants
n=484 Participants
|
236 Participants
n=473 Participants
|
469 Participants
n=957 Participants
|
|
DCIS laterality at diagnosis
Bilateral
|
4 Participants
n=484 Participants
|
2 Participants
n=473 Participants
|
6 Participants
n=957 Participants
|
|
DCIS grade at diagnosis
1
|
125 Participants
n=484 Participants
|
127 Participants
n=473 Participants
|
252 Participants
n=957 Participants
|
|
DCIS grade at diagnosis
2
|
359 Participants
n=484 Participants
|
346 Participants
n=473 Participants
|
705 Participants
n=957 Participants
|
|
DCIS estrogen receptor positive at diagnosis
|
473 Participants
n=484 Participants
|
467 Participants
n=473 Participants
|
940 Participants
n=957 Participants
|
|
DCIS progesterone receptor status at diagnosis
Positive
|
364 Participants
n=405 Participants • Some patients' receptor status was not collected
|
359 Participants
n=411 Participants • Some patients' receptor status was not collected
|
723 Participants
n=816 Participants • Some patients' receptor status was not collected
|
|
DCIS progesterone receptor status at diagnosis
Negative
|
41 Participants
n=405 Participants • Some patients' receptor status was not collected
|
52 Participants
n=411 Participants • Some patients' receptor status was not collected
|
93 Participants
n=816 Participants • Some patients' receptor status was not collected
|
|
DCIS ERBB2 status at diagnosis
0
|
1 Participants
n=4 Participants • Some patients' status was not collected
|
3 Participants
n=8 Participants • Some patients' status was not collected
|
4 Participants
n=12 Participants • Some patients' status was not collected
|
|
DCIS ERBB2 status at diagnosis
1+
|
3 Participants
n=4 Participants • Some patients' status was not collected
|
5 Participants
n=8 Participants • Some patients' status was not collected
|
8 Participants
n=12 Participants • Some patients' status was not collected
|
|
Premenopausal/perimenopausal
|
90 Participants
n=484 Participants
|
92 Participants
n=473 Participants
|
182 Participants
n=957 Participants
|
|
ECOG performance status score
0
|
431 Participants
n=484 Participants
|
410 Participants
n=473 Participants
|
841 Participants
n=957 Participants
|
|
ECOG performance status score
1
|
53 Participants
n=484 Participants
|
63 Participants
n=473 Participants
|
116 Participants
n=957 Participants
|
|
Comorbidities
|
284 Participants
n=484 Participants
|
256 Participants
n=473 Participants
|
540 Participants
n=957 Participants
|
|
Total No. of comorbidities
0
|
148 Participants
n=432 Participants • Analysis population is subset of patients who had any comorbidity
|
175 Participants
n=431 Participants • Analysis population is subset of patients who had any comorbidity
|
323 Participants
n=863 Participants • Analysis population is subset of patients who had any comorbidity
|
|
Total No. of comorbidities
1
|
137 Participants
n=432 Participants • Analysis population is subset of patients who had any comorbidity
|
124 Participants
n=431 Participants • Analysis population is subset of patients who had any comorbidity
|
261 Participants
n=863 Participants • Analysis population is subset of patients who had any comorbidity
|
|
Total No. of comorbidities
2
|
58 Participants
n=432 Participants • Analysis population is subset of patients who had any comorbidity
|
55 Participants
n=431 Participants • Analysis population is subset of patients who had any comorbidity
|
113 Participants
n=863 Participants • Analysis population is subset of patients who had any comorbidity
|
|
Total No. of comorbidities
3
|
34 Participants
n=432 Participants • Analysis population is subset of patients who had any comorbidity
|
27 Participants
n=431 Participants • Analysis population is subset of patients who had any comorbidity
|
61 Participants
n=863 Participants • Analysis population is subset of patients who had any comorbidity
|
|
Total No. of comorbidities
4
|
14 Participants
n=432 Participants • Analysis population is subset of patients who had any comorbidity
|
11 Participants
n=431 Participants • Analysis population is subset of patients who had any comorbidity
|
25 Participants
n=863 Participants • Analysis population is subset of patients who had any comorbidity
|
|
Total No. of comorbidities
5+
|
41 Participants
n=432 Participants • Analysis population is subset of patients who had any comorbidity
|
39 Participants
n=431 Participants • Analysis population is subset of patients who had any comorbidity
|
80 Participants
n=863 Participants • Analysis population is subset of patients who had any comorbidity
|
PRIMARY outcome
Timeframe: At 2 years follow-upTo compare the number of patients that develop ipsilateral invasive cancer that received surgery to the number of patients that were placed on active monitoring after 2 years of follow-up
Outcome measures
| Measure |
Active Monitoring
n=484 Participants
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression) \>
\> Active Monitoring: Choice for endocrine therapy
|
Surgery
n=473 Participants
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease) \>
\> Surgery: Surgery +/- radiation choice for endocrine therapy
|
|---|---|---|
|
Proportion of New Diagnoses of Ipsilateral Invasive Cancer in Surgery and AM Arms at 2 Years of Follow up
|
4.2 "percentage of participants
Interval 2.31 to 6.0
|
5.9 "percentage of participants
Interval 3.71 to 8.04
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 1 year, and once a year (years 2 through 5)Measured by Short Form (SF)-36
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 1 year, and once a year (years 2 through 5)Measured by five dimensions questionnaire (EQ-5D)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 1 year, and once a year (years 2 through 5)Measured by the State Trait Anxiety Inventory (STAI) scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 1 year, and once a year (years 2 through 5)Measured by the Center for Epidemiologic Studies Depression Scale (CES-D) 10
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineCoping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at 2 yearsAssessment of feelings of uncertainty using the Intolerance of Uncertainty Scale (Short-form), which has been used in studies of active monitoring in the prostate cancer setting.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2, 5, and 7 year follow-upTo compare the impact of surgery vs. AM on the number of mastectomies performed in patients with DCIS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2, 5, and 7 year follow-upTo compare the impact of surgery vs. AM on the number of breast conservation surgeries performed in patients with DCIS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2, 5, and 7 year follow-upTo compare the impact of surgery vs. AM on the rate of development of contralateral invasive cancer in patients with DCIS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2, 5, and 7 year follow-upTo compare the impact of surgery vs. AM on the overall survival rate in patients with DCIS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2, 5, and 7 year follow-upTo compare the impact of surgery vs. AM on the breast cancer specific survival rate in patients with DCIS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 and 7 year follow-upTo determine the number of DCIS patients in the surgery arm that develop ipsilateral invasive cancer
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 and 7 year follow-upTo determine the number of DCIS patients in the AM arm that develop ipsilateral invasive cancer
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2, 5, and 7 year follow-upDetermine the rate of use of breast MRI imaging compared to use of other breast imaging techniques
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2, 5, and 7 year follow-upDetermine the rate of biopsies performed during follow-up of patients with DCIS
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2, 5, and 7 year follow-upDetermine the rate of the performance of radiation therapy on patients with DCIS
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2, 5, and 7 year follow-upDetermine the rate of the use of chemotherapy on patients with DCIS
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months, 1 year, and once a year (years 2 through 5)Self-reported diary
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months, 1 year, and once a year (years 2 through 5)Evaluated with a drug diary
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 1 year, and once a year (years 2 through 5)A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate commonly reported menopausal symptoms
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 1 year, and once a year (years 2 through 5)Evaluated with the Brief Pain Inventory, a well-validated general measure of pain and disability worst pain, least pain, and interference
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 1 year, and once a year (years 2 through 5)Breast specific pain will be measured by the Breast Cancer Pain Questionnaire (BCPQ); the BCPQ includes assessment of pain severity, pain frequency (how many days/week), and pain location (breast, arm, side, axilla), from which a Pain Burden Index (PBI) can be calculated
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 1 year, and once a year (years 2 through 5)Body image will be evaluated by the Breast-Questionnaire, a validated instrument to evaluate outcomes following surgery, will be used to evaluate satisfaction with body image
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Years 1 through 5The Decision Regret Scale will measure how women perceived their DCIS treatment decision. The SURE scale, which is composed of four items from the Decisional Conflict Scale will be used to measure patients' uncertainty about which treatment to choose and factors contributing to uncertainty (feeling uninformed, unclear values, and unsupported in decision-making).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 yearsDCIS and breast cancer knowledge will be measured with items adapted from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) as well as questions developed specifically for a study that assessed DCIS knowledge and risk perceptions. The investigators will assess risk perceptions in women with DCIS using questions developed by Lerman and Croyle that will measure risk perceptions in relation to psychosocial outcomes in women with DCIS
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 yearsMeasured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineTo assess communication with physicians about DCIS management options, the investigators will adapt items used in a prior study of surgical decision-making, including the extent to which their physician talked to them about AM vs. surgery. Additionally the investigators will ask about sources of information for the management of their DCIS
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe investigators will adapt items from the National Health Interview Survey and the Cancer Outcomes Research and Surveillance (CanCORS) Study to assess financial burden. The investigators will also ask women to Cancer Care estimate out of pocket expenses attributed to their DCIS diagnosis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, year 1, and once a year (years 1 through 5)Employment status will be assessed using a measure that is being added to the Alliance Patient Questionnaire as it has been tested and validated in breast cancer populations.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 yearsFour items from the Quality of Life in Adult Cancer Survivors (QLACS) scale will be adapted to evaluate frequency (1=never; 7=always) of worries about DCIS, including concerns about future breast events and death from DCIS
Outcome measures
Outcome data not reported
Adverse Events
Active Monitoring
Serious events: 11 serious events
Other events: 378 other events
Deaths: 11 deaths
Surgery
Serious events: 8 serious events
Other events: 351 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Active Monitoring
n=484 participants at risk
Active Monitoring: Choice for endocrine therapy
|
Surgery
n=473 participants at risk
Surgery: Surgery +/- radiation choice for endocrine therapy
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Myocardial infarction
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
General disorders
Death NOS
|
1.2%
6/484 • Number of events 6 • Up to 2 years
|
0.85%
4/473 • Number of events 4 • Up to 2 years
|
|
Infections and infestations
Bladder infection
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
Other adverse events
| Measure |
Active Monitoring
n=484 participants at risk
Active Monitoring: Choice for endocrine therapy
|
Surgery
n=473 participants at risk
Surgery: Surgery +/- radiation choice for endocrine therapy
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
8/484 • Number of events 12 • Up to 2 years
|
1.1%
5/473 • Number of events 5 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.9%
9/484 • Number of events 16 • Up to 2 years
|
2.1%
10/473 • Number of events 10 • Up to 2 years
|
|
Nervous system disorders
Amnesia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.62%
3/484 • Number of events 4 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
Concentration impairment
|
0.62%
3/484 • Number of events 4 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
1.9%
9/484 • Number of events 11 • Up to 2 years
|
1.9%
9/473 • Number of events 15 • Up to 2 years
|
|
Nervous system disorders
Dysarthria
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Nervous system disorders
Dysesthesia
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Dysphasia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Glossopharyngeal nerve disorder
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Headache
|
2.5%
12/484 • Number of events 24 • Up to 2 years
|
2.1%
10/473 • Number of events 15 • Up to 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
1.1%
5/473 • Number of events 10 • Up to 2 years
|
|
Nervous system disorders
Memory impairment
|
0.83%
4/484 • Number of events 11 • Up to 2 years
|
1.3%
6/473 • Number of events 9 • Up to 2 years
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
1.1%
5/473 • Number of events 7 • Up to 2 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 4 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
0.85%
4/473 • Number of events 5 • Up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.2%
6/484 • Number of events 13 • Up to 2 years
|
1.9%
9/473 • Number of events 17 • Up to 2 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Seizure
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Nervous system disorders
Stroke
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Syncope
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Vasovagal reaction
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
1.9%
9/484 • Number of events 12 • Up to 2 years
|
1.5%
7/473 • Number of events 7 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 2 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
2.1%
10/484 • Number of events 18 • Up to 2 years
|
1.1%
5/473 • Number of events 7 • Up to 2 years
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 2 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
2.9%
14/484 • Number of events 16 • Up to 2 years
|
1.3%
6/473 • Number of events 22 • Up to 2 years
|
|
Psychiatric disorders
Libido decreased
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Personality change
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.21%
1/484 • Number of events 2 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.63%
3/473 • Number of events 4 • Up to 2 years
|
|
Renal and urinary disorders
Renal calculi
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.62%
3/484 • Number of events 3 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.83%
4/484 • Number of events 5 • Up to 2 years
|
1.3%
6/473 • Number of events 12 • Up to 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Renal and urinary disorders
Urine discoloration
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Reproductive system and breast disorders
Breast pain
|
3.1%
15/484 • Number of events 24 • Up to 2 years
|
2.5%
12/473 • Number of events 24 • Up to 2 years
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
0.85%
4/473 • Number of events 12 • Up to 2 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.62%
3/484 • Number of events 6 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
1.2%
6/484 • Number of events 7 • Up to 2 years
|
0.85%
4/473 • Number of events 6 • Up to 2 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.4%
7/484 • Number of events 23 • Up to 2 years
|
1.3%
6/473 • Number of events 14 • Up to 2 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.7%
8/484 • Number of events 16 • Up to 2 years
|
1.9%
9/473 • Number of events 28 • Up to 2 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.0%
5/484 • Number of events 5 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
6/484 • Number of events 8 • Up to 2 years
|
0.63%
3/473 • Number of events 4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
6/484 • Number of events 11 • Up to 2 years
|
1.7%
8/473 • Number of events 9 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.83%
4/484 • Number of events 4 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.4%
7/484 • Number of events 9 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.42%
2/473 • Number of events 4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
9/484 • Number of events 16 • Up to 2 years
|
1.9%
9/473 • Number of events 21 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
1.3%
6/473 • Number of events 17 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.62%
3/484 • Number of events 3 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.62%
3/484 • Number of events 3 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.62%
3/484 • Number of events 5 • Up to 2 years
|
0.85%
4/473 • Number of events 4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
1.2%
6/484 • Number of events 9 • Up to 2 years
|
1.5%
7/473 • Number of events 13 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/484 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Social circumstances
Menopause
|
0.21%
1/484 • Number of events 5 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Social circumstances
Social circumstances - Other, specify
|
0.00%
0/484 • Up to 2 years
|
0.63%
3/473 • Number of events 5 • Up to 2 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
1.7%
8/484 • Number of events 16 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Vascular disorders
Hematoma
|
0.21%
1/484 • Number of events 4 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Vascular disorders
Hot flashes
|
43.0%
208/484 • Number of events 688 • Up to 2 years
|
40.8%
193/473 • Number of events 723 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
47.3%
229/484 • Number of events 855 • Up to 2 years
|
41.9%
198/473 • Number of events 731 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/484 • Up to 2 years
|
0.63%
3/473 • Number of events 5 • Up to 2 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
0.83%
4/484 • Number of events 6 • Up to 2 years
|
0.63%
3/473 • Number of events 4 • Up to 2 years
|
|
General disorders
Fever
|
4.5%
22/484 • Number of events 30 • Up to 2 years
|
3.6%
17/473 • Number of events 22 • Up to 2 years
|
|
General disorders
Flu like symptoms
|
0.83%
4/484 • Number of events 8 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
General disorders
Gait disturbance
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.7%
8/484 • Number of events 10 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
General disorders
Localized edema
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
0.63%
3/473 • Number of events 5 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
General disorders
Pain
|
1.4%
7/484 • Number of events 13 • Up to 2 years
|
2.1%
10/473 • Number of events 12 • Up to 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
88/484 • Number of events 234 • Up to 2 years
|
18.6%
88/473 • Number of events 235 • Up to 2 years
|
|
Immune system disorders
Allergic reaction
|
3.3%
16/484 • Number of events 37 • Up to 2 years
|
2.5%
12/473 • Number of events 17 • Up to 2 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Breast infection
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Infections and infestations
Conjunctivitis
|
0.21%
1/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
19.0%
92/484 • Number of events 296 • Up to 2 years
|
20.7%
98/473 • Number of events 280 • Up to 2 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.9%
9/484 • Number of events 11 • Up to 2 years
|
1.9%
9/473 • Number of events 9 • Up to 2 years
|
|
Infections and infestations
Kidney infection
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Infections and infestations
Lung infection
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Otitis externa
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Infections and infestations
Otitis media
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Pharyngitis
|
0.21%
1/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Infections and infestations
Rash pustular
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Infections and infestations
Sepsis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Sinusitis
|
0.62%
3/484 • Number of events 6 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Infections and infestations
Skin infection
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Tooth infection
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
1.0%
5/484 • Number of events 5 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
1.5%
7/473 • Number of events 11 • Up to 2 years
|
|
Infections and infestations
Vaginal infection
|
0.83%
4/484 • Number of events 5 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Infections and infestations
Wound infection
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.83%
4/484 • Number of events 4 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
1.1%
5/473 • Number of events 5 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
4/484 • Number of events 4 • Up to 2 years
|
1.9%
9/473 • Number of events 10 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
6.0%
29/484 • Number of events 50 • Up to 2 years
|
4.4%
21/473 • Number of events 24 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.83%
4/484 • Number of events 7 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.62%
3/484 • Number of events 4 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
0.62%
3/484 • Number of events 5 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.83%
4/484 • Number of events 5 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Investigations
Cholesterol high
|
16.5%
80/484 • Number of events 216 • Up to 2 years
|
16.1%
76/473 • Number of events 175 • Up to 2 years
|
|
Investigations
Creatinine increased
|
0.41%
2/484 • Number of events 4 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Investigations
Investigations - Other, specify
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.63%
3/473 • Number of events 12 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
Investigations
Weight gain
|
1.2%
6/484 • Number of events 8 • Up to 2 years
|
2.1%
10/473 • Number of events 17 • Up to 2 years
|
|
Investigations
Weight loss
|
1.0%
5/484 • Number of events 12 • Up to 2 years
|
0.63%
3/473 • Number of events 7 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
0.62%
3/484 • Number of events 3 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.83%
4/484 • Number of events 7 • Up to 2 years
|
0.63%
3/473 • Number of events 4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.2%
6/484 • Number of events 13 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.21%
1/484 • Number of events 3 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Obesity
|
1.9%
9/484 • Number of events 20 • Up to 2 years
|
1.7%
8/473 • Number of events 14 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.8%
178/484 • Number of events 596 • Up to 2 years
|
35.3%
167/473 • Number of events 528 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.5%
12/484 • Number of events 20 • Up to 2 years
|
0.63%
3/473 • Number of events 5 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
11/484 • Number of events 11 • Up to 2 years
|
2.3%
11/473 • Number of events 20 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.62%
3/484 • Number of events 4 • Up to 2 years
|
0.63%
3/473 • Number of events 5 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.62%
3/484 • Number of events 5 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.83%
4/484 • Number of events 6 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
1.7%
8/484 • Number of events 10 • Up to 2 years
|
3.4%
16/473 • Number of events 39 • Up to 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.21%
1/484 • Number of events 3 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Cardiac disorders
Mobitz (type) II atrioventricular block
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Cardiac disorders
Mobitz type I
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Cardiac disorders
Myocardial infarction
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Palpitations
|
1.0%
5/484 • Number of events 6 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.83%
4/484 • Number of events 4 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
0.85%
4/473 • Number of events 5 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.21%
1/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.41%
2/484 • Number of events 4 • Up to 2 years
|
0.63%
3/473 • Number of events 6 • Up to 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.21%
1/484 • Number of events 5 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.21%
1/484 • Number of events 2 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
1.0%
5/484 • Number of events 7 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Eye disorders
Cataract
|
0.62%
3/484 • Number of events 3 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Eye disorders
Dry eye
|
0.83%
4/484 • Number of events 7 • Up to 2 years
|
0.21%
1/473 • Number of events 2 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.21%
1/484 • Number of events 4 • Up to 2 years
|
0.42%
2/473 • Number of events 4 • Up to 2 years
|
|
Eye disorders
Eye pain
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Floaters
|
0.21%
1/484 • Number of events 4 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Eye disorders
Photophobia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Retinopathy
|
0.21%
1/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
5/484 • Number of events 8 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.83%
4/484 • Number of events 4 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Dental caries
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
6/484 • Number of events 9 • Up to 2 years
|
1.3%
6/473 • Number of events 6 • Up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.4%
7/484 • Number of events 13 • Up to 2 years
|
0.63%
3/473 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroparesis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
10.3%
50/484 • Number of events 117 • Up to 2 years
|
9.1%
43/473 • Number of events 77 • Up to 2 years
|
|
Gastrointestinal disorders
Oral pain
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/484 • Up to 2 years
|
0.42%
2/473 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Typhlitis
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.83%
4/484 • Number of events 4 • Up to 2 years
|
0.85%
4/473 • Number of events 4 • Up to 2 years
|
|
General disorders
Chills
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.42%
2/473 • Number of events 9 • Up to 2 years
|
|
General disorders
Edema limbs
|
2.1%
10/484 • Number of events 14 • Up to 2 years
|
1.7%
8/473 • Number of events 11 • Up to 2 years
|
|
General disorders
Fatigue
|
5.6%
27/484 • Number of events 62 • Up to 2 years
|
6.1%
29/473 • Number of events 46 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
8/484 • Number of events 12 • Up to 2 years
|
1.5%
7/473 • Number of events 10 • Up to 2 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.21%
1/484 • Number of events 3 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.00%
0/484 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.41%
2/484 • Number of events 2 • Up to 2 years
|
0.63%
3/473 • Number of events 8 • Up to 2 years
|
|
Cardiac disorders
Aortic valve disease
|
0.21%
1/484 • Number of events 1 • Up to 2 years
|
0.21%
1/473 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.41%
2/484 • Number of events 3 • Up to 2 years
|
0.63%
3/473 • Number of events 3 • Up to 2 years
|
|
Cardiac disorders
Atrioventricular block complete
|
0.21%
1/484 • Number of events 2 • Up to 2 years
|
0.00%
0/473 • Up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.21%
1/484 • Number of events 2 • Up to 2 years
|
0.21%
1/473 • Number of events 2 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place