Trial Outcomes & Findings for Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (NCT NCT02947685)
NCT ID: NCT02947685
Last Updated: 2026-02-12
Results Overview
The time from registration to disease progression or death.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
518 participants
Primary outcome timeframe
7 years 3 months
Results posted on
2026-02-12
Participant Flow
Participant milestones
| Measure |
Arm A
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Overall Study
STARTED
|
261
|
257
|
|
Overall Study
COMPLETED
|
261
|
257
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=261 Participants
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=257 Participants
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
Total
n=518 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
n=41 Participants
|
53 years
n=1581 Participants
|
53.4 years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
259 Participants
n=41 Participants
|
256 Participants
n=1581 Participants
|
515 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=41 Participants
|
25 Participants
n=1581 Participants
|
71 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=41 Participants
|
136 Participants
n=1581 Participants
|
256 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
95 Participants
n=41 Participants
|
96 Participants
n=1581 Participants
|
191 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
207 Participants
n=41 Participants
|
194 Participants
n=1581 Participants
|
401 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=41 Participants
|
45 Participants
n=1581 Participants
|
81 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 7 years 3 monthsThe time from registration to disease progression or death.
Outcome measures
| Measure |
Arm A
n=261 Participants
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=257 Participants
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Investigator
|
44.3 months
Interval 32.4 to 56.8
|
29.1 months
Interval 23.3 to 38.6
|
SECONDARY outcome
Timeframe: 7 years 3 monthsDefined as time from date of randomization to date of death due to any cause
Outcome measures
| Measure |
Arm A
n=261 Participants
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=257 Participants
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 71.6 to
Too few events occurred to calculate the median and upper CI limit
|
77 Months
Interval 72.0 to
Too few events occurred to calculate the upper CI limit
|
SECONDARY outcome
Timeframe: 5 yearsDefined as the percentage of patients still alive and followed at 3 and 5 years post beginning of treatment.
Outcome measures
| Measure |
Arm A
n=261 Participants
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=257 Participants
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
3 and 5 Year Survival Probabilities
At 3 years
|
87 percentage of patients alive
Interval 82.8 to 91.2
|
84.7 percentage of patients alive
Interval 80.0 to 89.3
|
|
3 and 5 Year Survival Probabilities
At 5 years
|
72.9 percentage of patients alive
Interval 66.0 to 79.7
|
68.5 percentage of patients alive
Interval 61.1 to 76.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Patients evaluated for disease
Defined as proportion of patients that achieve complete response (CR) or partial response (PR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A
n=231 Participants
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=230 Participants
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Objective Response Rate (OR: CR or PR)
|
0.329 proportion of participants
|
0.248 proportion of participants
|
SECONDARY outcome
Timeframe: 72 monthsPopulation: Patients that achieved confirmed response
Defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death from any cause, whichever occurs first
Outcome measures
| Measure |
Arm A
n=76 Participants
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=57 Participants
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Duration of Response (DOR)
|
44.9 Months
Interval 27.1 to 51.6
|
30.8 Months
Interval 26.0 to
Upper limit not available due to low number of events
|
SECONDARY outcome
Timeframe: 24 monthsThe Clinical Benefit Rate (CBR) on each treatment arm will be estimated by dividing the number of patients with CR, PR, or SD/Non-CR and Non-PD (for patients with measurable disease) for ≥ 24 weeks by the number of patients randomized to the treatment arm.
Outcome measures
| Measure |
Arm A
n=261 Participants
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=257 Participants
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Clinical Benefit Rate
|
0.889 proportion of participants
|
0.809 proportion of participants
|
SECONDARY outcome
Timeframe: 24 monthsThe proportion of patient by arm that experienced grade 3 or higher adverse events will be reported
Outcome measures
| Measure |
Arm A
n=261 Participants
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=257 Participants
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Incidence of Grade 3 or Higher Adverse Events (as Graded by NCI CTCAE v 4.0)
|
0.797 proportion of participants
|
0.306 proportion of participants
|
SECONDARY outcome
Timeframe: 24 monthsTime to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsCompare the incidence of CNS metastasis between treatment arms
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Palbociclib PK assessment: Day 22, Cycle 1, No; Pertuzumab, Trastuzumab PK assessment: Day 1, Cycle 4only for patients enrolled in the US
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Cycle 1, Day 1, Cycle 4, End of Treatment, approx 24 monthsProgression Free Survival (PFS) based upon investigator assessment of progression between patients in the two treatment arms in the subset of patients with tumors bearing a PIK3CA mutation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineWill evaluate baseline tumor and blood-based markers as predictors of benefit from the addition of palbociclib to anti-HER2 therapy plus endocrine therapy
Outcome measures
Outcome data not reported
Adverse Events
Arm A
Serious events: 75 serious events
Other events: 261 other events
Deaths: 60 deaths
Arm B
Serious events: 54 serious events
Other events: 234 other events
Deaths: 63 deaths
Serious adverse events
| Measure |
Arm A
n=261 participants at risk
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=257 participants at risk
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Diarrhea
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Bronchial infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Syncope
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Hypertension
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Thromboembolic event
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Heart failure
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Blurred vision
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Papilledema
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Anal fistula
|
0.38%
1/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
1.5%
4/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Nausea
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Death NOS
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Fever
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Flu like symptoms
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Non-cardiac chest pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Pain
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Appendicitis
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Device related infection
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Duodenal infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Endocarditis infective
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Infections and infestations - Oth spec
|
3.8%
10/261 • Number of events 11 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Joint infection
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Kidney infection
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Lung infection
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Sepsis
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Skin infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Small intestine infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Upper respiratory infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Urinary tract infection
|
1.9%
5/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Bruising
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
6/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Dehydration
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Dizziness
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Headache
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
1.1%
3/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Seizure
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Stroke
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Transient ischemic attacks
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Confusion
|
0.38%
1/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Delirium
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Acute kidney injury
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.38%
1/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Renal colic
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Urinary incontinence
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Hematoma
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
Other adverse events
| Measure |
Arm A
n=261 participants at risk
Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
|
Arm B
n=257 participants at risk
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
|
|---|---|---|
|
Gastrointestinal disorders
Hemorrhoids
|
6.5%
17/261 • Number of events 19 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Lip pain
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Fever
|
15.7%
41/261 • Number of events 60 • 5 years for adverse events and 7 years 3 months for mortality
|
5.4%
14/257 • Number of events 22 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Flu like symptoms
|
8.0%
21/261 • Number of events 29 • 5 years for adverse events and 7 years 3 months for mortality
|
7.0%
18/257 • Number of events 35 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Gait disturbance
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Rhinitis infective
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.3%
19/261 • Number of events 30 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 18 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.3%
40/261 • Number of events 78 • 5 years for adverse events and 7 years 3 months for mortality
|
5.1%
13/257 • Number of events 21 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Dysesthesia
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Dysgeusia
|
3.8%
10/261 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Dysphasia
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Headache
|
24.9%
65/261 • Number of events 86 • 5 years for adverse events and 7 years 3 months for mortality
|
17.9%
46/257 • Number of events 67 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Hypersomnia
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Lethargy
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Memory impairment
|
1.5%
4/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Movements involuntary
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Depression
|
2.7%
7/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
3.1%
8/257 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Insomnia
|
11.5%
30/261 • Number of events 42 • 5 years for adverse events and 7 years 3 months for mortality
|
11.3%
29/257 • Number of events 31 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Irritability
|
0.38%
1/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Libido decreased
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Personality change
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Hypotension
|
1.5%
4/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Lymphedema
|
3.8%
10/261 • Number of events 13 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Lymphocele
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Phlebitis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Thromboembolic event
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
3.1%
8/257 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Mitral valve disease
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Palpitations
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Pulmonary valve disease
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Sinus bradycardia
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Sinus tachycardia
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Ventricular tachycardia
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Congenital, familial and genetic disorders
Congen, family, genetic disord -Oth spec
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
3.1%
8/261 • Number of events 8 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Ear and labyrinth disorders
Ear pain
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Ear and labyrinth disorders
Tinnitus
|
1.1%
3/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
13/261 • Number of events 17 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 8 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Endocrine disorders
Hyperthyroidism
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Endocrine disorders
Hypothyroidism
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Endocrine disorders
Virilization
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Blurred vision
|
4.6%
12/261 • Number of events 22 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Cataract
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Dry eye
|
5.0%
13/261 • Number of events 18 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Eye disorders - Other, specify
|
11.1%
29/261 • Number of events 41 • 5 years for adverse events and 7 years 3 months for mortality
|
3.5%
9/257 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Eye pain
|
1.9%
5/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Flashing lights
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Floaters
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Glaucoma
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Keratitis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Periorbital edema
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Photophobia
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Uveitis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Eye disorders
Watering eyes
|
5.0%
13/261 • Number of events 16 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Abdominal distension
|
0.38%
1/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
46/261 • Number of events 58 • 5 years for adverse events and 7 years 3 months for mortality
|
6.2%
16/257 • Number of events 16 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Anal fistula
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Anal mucositis
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Anal pain
|
1.9%
5/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Anal ulcer
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Cheilitis
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Colitis
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Constipation
|
12.6%
33/261 • Number of events 42 • 5 years for adverse events and 7 years 3 months for mortality
|
9.3%
24/257 • Number of events 32 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Dental caries
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Diarrhea
|
69.7%
182/261 • Number of events 551 • 5 years for adverse events and 7 years 3 months for mortality
|
35.8%
92/257 • Number of events 166 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Dry mouth
|
2.7%
7/261 • Number of events 8 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
9/261 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
6/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Esophageal obstruction
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Esophagitis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
11/261 • Number of events 14 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.9%
18/261 • Number of events 22 • 5 years for adverse events and 7 years 3 months for mortality
|
3.5%
9/257 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
12.6%
33/261 • Number of events 59 • 5 years for adverse events and 7 years 3 months for mortality
|
5.1%
13/257 • Number of events 19 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.3%
6/261 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Gingival pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Anemia
|
32.2%
84/261 • Number of events 205 • 5 years for adverse events and 7 years 3 months for mortality
|
9.3%
24/257 • Number of events 75 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
8.0%
21/261 • Number of events 38 • 5 years for adverse events and 7 years 3 months for mortality
|
3.1%
8/257 • Number of events 13 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.1%
8/261 • Number of events 8 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Heart failure
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Mucositis oral
|
34.9%
91/261 • Number of events 235 • 5 years for adverse events and 7 years 3 months for mortality
|
6.6%
17/257 • Number of events 21 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Nausea
|
28.7%
75/261 • Number of events 132 • 5 years for adverse events and 7 years 3 months for mortality
|
15.6%
40/257 • Number of events 58 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Oral pain
|
3.4%
9/261 • Number of events 15 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Periodontal disease
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.4%
9/261 • Number of events 11 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Rectal pain
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Stomach pain
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Toothache
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Gastrointestinal disorders
Vomiting
|
14.6%
38/261 • Number of events 68 • 5 years for adverse events and 7 years 3 months for mortality
|
8.2%
21/257 • Number of events 33 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Chills
|
1.9%
5/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Edema face
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Edema limbs
|
6.9%
18/261 • Number of events 23 • 5 years for adverse events and 7 years 3 months for mortality
|
5.8%
15/257 • Number of events 18 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Facial pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Fatigue
|
51.7%
135/261 • Number of events 346 • 5 years for adverse events and 7 years 3 months for mortality
|
37.4%
96/257 • Number of events 152 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
16.9%
44/261 • Number of events 58 • 5 years for adverse events and 7 years 3 months for mortality
|
7.4%
19/257 • Number of events 27 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Injection site reaction
|
1.9%
5/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Localized edema
|
3.1%
8/261 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Malaise
|
1.9%
5/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Neck edema
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Non-cardiac chest pain
|
5.0%
13/261 • Number of events 14 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
General disorders
Pain
|
22.2%
58/261 • Number of events 120 • 5 years for adverse events and 7 years 3 months for mortality
|
24.1%
62/257 • Number of events 152 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Hepatobiliary disorders
Cholecystitis
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Hepatobiliary disorders
Hepatic pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Immune system disorders
Allergic reaction
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Immune system disorders
Autoimmune disorder
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Immune system disorders
Immune system disorders - Other, specify
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Bladder infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Bronchial infection
|
5.4%
14/261 • Number of events 17 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Conjunctivitis
|
5.0%
13/261 • Number of events 16 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Enterocolitis infectious
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Eye infection
|
0.77%
2/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Gum infection
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Infections and infestations - Oth spec
|
31.8%
83/261 • Number of events 118 • 5 years for adverse events and 7 years 3 months for mortality
|
13.6%
35/257 • Number of events 51 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Laryngitis
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Lip infection
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Lung infection
|
4.2%
11/261 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Mucosal infection
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Nail infection
|
5.7%
15/261 • Number of events 22 • 5 years for adverse events and 7 years 3 months for mortality
|
5.1%
13/257 • Number of events 14 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Otitis externa
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Otitis media
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Papulopustular rash
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Paronychia
|
3.4%
9/261 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Peripheral nerve infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Pharyngitis
|
1.9%
5/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Phlebitis infective
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Rash pustular
|
1.9%
5/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Salivary gland infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Sinusitis
|
5.7%
15/261 • Number of events 17 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Skin infection
|
10.0%
26/261 • Number of events 46 • 5 years for adverse events and 7 years 3 months for mortality
|
5.4%
14/257 • Number of events 22 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Soft tissue infection
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Tooth infection
|
3.8%
10/261 • Number of events 11 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Tracheitis
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Upper respiratory infection
|
14.6%
38/261 • Number of events 52 • 5 years for adverse events and 7 years 3 months for mortality
|
9.3%
24/257 • Number of events 36 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Urinary tract infection
|
10.0%
26/261 • Number of events 57 • 5 years for adverse events and 7 years 3 months for mortality
|
7.8%
20/257 • Number of events 32 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Uterine infection
|
0.38%
1/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Infections and infestations
Vaginal infection
|
3.1%
8/261 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Bruising
|
3.8%
10/261 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Fall
|
5.7%
15/261 • Number of events 26 • 5 years for adverse events and 7 years 3 months for mortality
|
3.5%
9/257 • Number of events 15 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Fracture
|
5.4%
14/261 • Number of events 16 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Seroma
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.38%
1/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Activated partial throm time prolonged
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Alanine aminotransferase increased
|
12.3%
32/261 • Number of events 63 • 5 years for adverse events and 7 years 3 months for mortality
|
3.5%
9/257 • Number of events 11 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Alkaline phosphatase increased
|
5.0%
13/261 • Number of events 21 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Aspartate aminotransferase increased
|
12.6%
33/261 • Number of events 63 • 5 years for adverse events and 7 years 3 months for mortality
|
3.9%
10/257 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Blood bilirubin increased
|
1.9%
5/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Cholesterol high
|
1.9%
5/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Creatinine increased
|
5.4%
14/261 • Number of events 29 • 5 years for adverse events and 7 years 3 months for mortality
|
3.1%
8/257 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Ejection fraction decreased
|
8.4%
22/261 • Number of events 32 • 5 years for adverse events and 7 years 3 months for mortality
|
10.9%
28/257 • Number of events 51 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Forced expiratory volume decreased
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
GGT increased
|
1.1%
3/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Investigations - Other, specify
|
5.7%
15/261 • Number of events 60 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 16 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Lipase increased
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Lymphocyte count decreased
|
12.3%
32/261 • Number of events 145 • 5 years for adverse events and 7 years 3 months for mortality
|
3.9%
10/257 • Number of events 37 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Neutrophil count decreased
|
75.1%
196/261 • Number of events 1618 • 5 years for adverse events and 7 years 3 months for mortality
|
7.8%
20/257 • Number of events 32 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Platelet count decreased
|
22.6%
59/261 • Number of events 174 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Weight gain
|
2.3%
6/261 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
Weight loss
|
4.2%
11/261 • Number of events 14 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 21 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Investigations
White blood cell decreased
|
37.5%
98/261 • Number of events 613 • 5 years for adverse events and 7 years 3 months for mortality
|
3.9%
10/257 • Number of events 31 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Anorexia
|
13.0%
34/261 • Number of events 50 • 5 years for adverse events and 7 years 3 months for mortality
|
4.7%
12/257 • Number of events 14 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.1%
16/261 • Number of events 30 • 5 years for adverse events and 7 years 3 months for mortality
|
3.9%
10/257 • Number of events 31 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.9%
5/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.8%
10/261 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.6%
12/261 • Number of events 25 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
6/261 • Number of events 8 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.3%
66/261 • Number of events 97 • 5 years for adverse events and 7 years 3 months for mortality
|
33.1%
85/257 • Number of events 145 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.2%
11/261 • Number of events 16 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
27/261 • Number of events 38 • 5 years for adverse events and 7 years 3 months for mortality
|
11.3%
29/257 • Number of events 33 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
21/261 • Number of events 26 • 5 years for adverse events and 7 years 3 months for mortality
|
5.8%
15/257 • Number of events 17 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
13/261 • Number of events 14 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.9%
5/261 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
19.5%
51/261 • Number of events 69 • 5 years for adverse events and 7 years 3 months for mortality
|
14.8%
38/257 • Number of events 58 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
27/261 • Number of events 37 • 5 years for adverse events and 7 years 3 months for mortality
|
11.3%
29/257 • Number of events 37 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
7/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
2.3%
6/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.6%
33/261 • Number of events 55 • 5 years for adverse events and 7 years 3 months for mortality
|
8.2%
21/257 • Number of events 30 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.9%
5/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Amnesia
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Aphonia
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Central nervous system necrosis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Cognitive disturbance
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Concentration impairment
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Depressed level of consciousness
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Dizziness
|
14.2%
37/261 • Number of events 50 • 5 years for adverse events and 7 years 3 months for mortality
|
8.2%
21/257 • Number of events 27 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.38%
1/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
4.2%
11/261 • Number of events 11 • 5 years for adverse events and 7 years 3 months for mortality
|
5.1%
13/257 • Number of events 17 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Neuralgia
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Paresthesia
|
7.3%
19/261 • Number of events 21 • 5 years for adverse events and 7 years 3 months for mortality
|
3.1%
8/257 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.8%
10/261 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
4.3%
11/257 • Number of events 14 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.2%
50/261 • Number of events 59 • 5 years for adverse events and 7 years 3 months for mortality
|
10.9%
28/257 • Number of events 38 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Presyncope
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Seizure
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Somnolence
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Spasticity
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Stroke
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Syncope
|
1.1%
3/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Nervous system disorders
Tremor
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Agitation
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Anxiety
|
5.4%
14/261 • Number of events 18 • 5 years for adverse events and 7 years 3 months for mortality
|
6.6%
17/257 • Number of events 19 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Confusion
|
1.1%
3/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.7%
7/261 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
3.5%
9/257 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Acute kidney injury
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.5%
4/261 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Hematuria
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Renal calculi
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Urinary frequency
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Urinary incontinence
|
1.9%
5/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Urinary retention
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Urinary tract pain
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Renal and urinary disorders
Urinary urgency
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Breast pain
|
3.8%
10/261 • Number of events 12 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Dyspareunia
|
3.1%
8/261 • Number of events 8 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
2.7%
7/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Uterine pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Vaginal dryness
|
10.7%
28/261 • Number of events 31 • 5 years for adverse events and 7 years 3 months for mortality
|
3.9%
10/257 • Number of events 11 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.38%
1/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.9%
18/261 • Number of events 20 • 5 years for adverse events and 7 years 3 months for mortality
|
3.5%
9/257 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.9%
39/261 • Number of events 55 • 5 years for adverse events and 7 years 3 months for mortality
|
10.9%
28/257 • Number of events 36 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
26/261 • Number of events 37 • 5 years for adverse events and 7 years 3 months for mortality
|
9.7%
25/257 • Number of events 36 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.6%
46/261 • Number of events 59 • 5 years for adverse events and 7 years 3 months for mortality
|
5.1%
13/257 • Number of events 14 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.77%
2/261 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.3%
19/261 • Number of events 20 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.9%
5/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.3%
6/261 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
1.6%
4/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
9.2%
24/261 • Number of events 36 • 5 years for adverse events and 7 years 3 months for mortality
|
3.1%
8/257 • Number of events 11 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.1%
16/261 • Number of events 26 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 7 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.7%
28/261 • Number of events 30 • 5 years for adverse events and 7 years 3 months for mortality
|
3.5%
9/257 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.8%
23/261 • Number of events 30 • 5 years for adverse events and 7 years 3 months for mortality
|
5.1%
13/257 • Number of events 18 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.3%
6/261 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
2.7%
7/257 • Number of events 8 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.00%
0/257 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.4%
9/261 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 5 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.4%
9/261 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 6 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
3.4%
9/261 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
3.1%
8/257 • Number of events 8 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
1.1%
3/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.1%
55/261 • Number of events 95 • 5 years for adverse events and 7 years 3 months for mortality
|
16.3%
42/257 • Number of events 60 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.3%
19/261 • Number of events 24 • 5 years for adverse events and 7 years 3 months for mortality
|
4.7%
12/257 • Number of events 16 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.2%
24/261 • Number of events 39 • 5 years for adverse events and 7 years 3 months for mortality
|
10.1%
26/257 • Number of events 29 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.77%
2/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 2 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
24.1%
63/261 • Number of events 128 • 5 years for adverse events and 7 years 3 months for mortality
|
14.0%
36/257 • Number of events 65 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.38%
1/261 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
0.78%
2/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/261 • 5 years for adverse events and 7 years 3 months for mortality
|
0.39%
1/257 • Number of events 1 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Flushing
|
1.1%
3/261 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
3.1%
8/257 • Number of events 9 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Hematoma
|
1.5%
4/261 • Number of events 4 • 5 years for adverse events and 7 years 3 months for mortality
|
1.2%
3/257 • Number of events 3 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Hot flashes
|
21.1%
55/261 • Number of events 91 • 5 years for adverse events and 7 years 3 months for mortality
|
24.5%
63/257 • Number of events 81 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Hypertension
|
8.0%
21/261 • Number of events 37 • 5 years for adverse events and 7 years 3 months for mortality
|
8.2%
21/257 • Number of events 28 • 5 years for adverse events and 7 years 3 months for mortality
|
|
Vascular disorders
Vascular disorders - Other, specify
|
3.1%
8/261 • Number of events 17 • 5 years for adverse events and 7 years 3 months for mortality
|
1.9%
5/257 • Number of events 10 • 5 years for adverse events and 7 years 3 months for mortality
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place