Trial Outcomes & Findings for Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer (NCT NCT03012100)
NCT ID: NCT03012100
Last Updated: 2026-06-30
Results Overview
Will be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
280 participants
Primary outcome timeframe
7 years
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
Arm I (FRalpha Peptide Vaccine, Sargramostim)
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
\>
\> Cyclophosphamide: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Multi-epitope Folate Receptor Alpha Peptide Vaccine: Given ID
\>
\> Sargramostim: Given ID
|
Arm II (Placebo, Sargramostim)
Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
\>
\> Cyclophosphamide: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Placebo Administration: Given ID
\>
\> Sargramostim: Given ID
|
|---|---|---|
|
Overall Study
STARTED
|
193
|
87
|
|
Overall Study
Received treatment
|
187
|
85
|
|
Overall Study
COMPLETED
|
58
|
30
|
|
Overall Study
NOT COMPLETED
|
135
|
57
|
Reasons for withdrawal
| Measure |
Arm I (FRalpha Peptide Vaccine, Sargramostim)
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
\>
\> Cyclophosphamide: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Multi-epitope Folate Receptor Alpha Peptide Vaccine: Given ID
\>
\> Sargramostim: Given ID
|
Arm II (Placebo, Sargramostim)
Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.
\>
\> Cyclophosphamide: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Placebo Administration: Given ID
\>
\> Sargramostim: Given ID
|
|---|---|---|
|
Overall Study
Disease progression
|
23
|
7
|
|
Overall Study
Adverse Event
|
12
|
6
|
|
Overall Study
Withdrawal by Subject
|
18
|
3
|
|
Overall Study
Alternative therapy
|
1
|
0
|
|
Overall Study
Withdrawn due to early closure
|
66
|
32
|
|
Overall Study
Non-compliance
|
4
|
3
|
|
Overall Study
Complicating disease
|
2
|
1
|
|
Overall Study
Insurance issues
|
2
|
0
|
|
Overall Study
Withdrawn to undergo surgery
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Dosing error
|
0
|
1
|
|
Overall Study
Withdrawal prior to receiving treatment
|
6
|
2
|
Baseline Characteristics
Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I (FRalpha Peptide Vaccine, Sargramostim)
n=193 Participants
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.\> \> Cyclophosphamide: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Multi-epitope Folate Receptor Alpha Peptide Vaccine: Given ID\>
\> Sargramostim: Given ID
|
Arm II (Placebo, Sargramostim)
n=87 Participants
Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.\> \> Cyclophosphamide: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Placebo Administration: Given ID\>
\> Sargramostim: Given ID
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 10.43 • n=20 Participants
|
53.4 years
STANDARD_DEVIATION 11.02 • n=20 Participants
|
52.6 years
STANDARD_DEVIATION 10.61 • n=40 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=20 Participants
|
87 Participants
n=20 Participants
|
280 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=20 Participants
|
74 Participants
n=20 Participants
|
239 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
163 Participants
n=20 Participants
|
68 Participants
n=20 Participants
|
231 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
193 participants
n=20 Participants
|
87 participants
n=20 Participants
|
280 participants
n=40 Participants
|
|
Prior treatment
Adjuvant
|
137 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
198 Participants
n=40 Participants
|
|
Prior treatment
Neo-adjuvant chemotherapy
|
56 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
82 Participants
n=40 Participants
|
|
Disease stage
I/II
|
151 Participants
n=20 Participants
|
68 Participants
n=20 Participants
|
219 Participants
n=40 Participants
|
|
Disease stage
III
|
42 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 7 yearsWill be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
Outcome measures
| Measure |
Arm I (FRalpha Peptide Vaccine, Sargramostim)
n=193 Participants
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.\> \> Cyclophosphamide: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Multi-epitope Folate Receptor Alpha Peptide Vaccine: Given ID\>
\> Sargramostim: Given ID
|
Arm II (Placebo, Sargramostim)
n=87 Participants
Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.\> \> Cyclophosphamide: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Placebo Administration: Given ID\>
\> Sargramostim: Given ID
|
|---|---|---|
|
Disease-free Survival
|
NA months
The median, lower CI, and upper CI are not estimable due to a low number or events
|
NA months
The median, lower CI, and upper CI are not estimable due to a low number or events
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Only patients that began treatment were included in analysis
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed by primary disease site to determine toxicity patterns. The number of patients experiencing a grade 3 or greater AE regardless of attribution will be reported.
Outcome measures
| Measure |
Arm I (FRalpha Peptide Vaccine, Sargramostim)
n=187 Participants
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.\> \> Cyclophosphamide: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Multi-epitope Folate Receptor Alpha Peptide Vaccine: Given ID\>
\> Sargramostim: Given ID
|
Arm II (Placebo, Sargramostim)
n=85 Participants
Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.\> \> Cyclophosphamide: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Placebo Administration: Given ID\>
\> Sargramostim: Given ID
|
|---|---|---|
|
Number of Patients Experiencing Grade 3 or Greater Adverse Events Assessed by Common Terminology Criteria for Adverse Events 4.0
|
41 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 7 yearsWill be estimated using the method of Kaplan-Meier. Will use the stratified log-rank tests.
Outcome measures
| Measure |
Arm I (FRalpha Peptide Vaccine, Sargramostim)
n=193 Participants
Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.\> \> Cyclophosphamide: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Multi-epitope Folate Receptor Alpha Peptide Vaccine: Given ID\>
\> Sargramostim: Given ID
|
Arm II (Placebo, Sargramostim)
n=87 Participants
Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.\> \> Cyclophosphamide: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Placebo Administration: Given ID\>
\> Sargramostim: Given ID
|
|---|---|---|
|
Overall Survival
|
NA months
The median, lower CI, and upper CI are not estimable due to a low number or events
|
NA months
The median, lower CI, and upper CI are not estimable due to a low number or events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion (average of 5 years)FRalpha levels at baseline will be examined as a prognostic factor in the vaccine immune response. A multivariable Cox proportional hazard model will be used to assess baseline FRalpha levels as a potential prognostic factor for immune response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion (average of 5 years)Will be determined along with its corresponding 95% confidence interval.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (FRalpha Peptide Vaccine, Sargramostim)
Serious events: 38 serious events
Other events: 182 other events
Deaths: 11 deaths
Arm II (Placebo, Sargramostim)
Serious events: 14 serious events
Other events: 83 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm I (FRalpha Peptide Vaccine, Sargramostim)
n=187 participants at risk
Sargramostim: Given ID
|
Arm II (Placebo, Sargramostim)
n=85 participants at risk
Sargramostim: Given ID
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Fatigue
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
4.7%
4/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Gen disord and admin site conds-Oth spec
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Injection site reaction
|
2.7%
5/187 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Pain
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Immune system disorders
Allergic reaction
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Abdominal infection
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Lung infection
|
1.6%
3/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Meningitis
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Papulopustular rash
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Lymphocyte count decreased
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Neutrophil count decreased
|
1.6%
3/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Platelet count decreased
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
White blood cell decreased
|
1.6%
3/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Headache
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Syncope
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Anxiety
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Depression
|
1.1%
2/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Suicide attempt
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Thromboembolic event
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
Other adverse events
| Measure |
Arm I (FRalpha Peptide Vaccine, Sargramostim)
n=187 participants at risk
Sargramostim: Given ID
|
Arm II (Placebo, Sargramostim)
n=85 participants at risk
Sargramostim: Given ID
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.1%
2/187 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Eye disorders
Dry eye
|
0.53%
1/187 • Number of events 10 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Eye disorders
Eye disorders - Other, specify
|
1.6%
3/187 • Number of events 21 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Cardiac disorders
Palpitations
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Cardiac disorders
Sinus bradycardia
|
0.53%
1/187 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Eye disorders
Floaters
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Endocrine disorders
Hyperthyroidism
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Endocrine disorders
Hypoparathyroidism
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Endocrine disorders
Hypothyroidism
|
1.6%
3/187 • Number of events 9 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Eye disorders
Blurred vision
|
1.1%
2/187 • Number of events 10 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Blood and lymphatic system disorders
Anemia
|
26.2%
49/187 • Number of events 119 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
21.2%
18/85 • Number of events 52 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
4.8%
9/187 • Number of events 18 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Eye disorders
Watering eyes
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
10/187 • Number of events 12 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
4.7%
4/85 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Bloating
|
1.1%
2/187 • Number of events 9 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Cheilitis
|
0.53%
1/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Colitis
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
12.3%
23/187 • Number of events 109 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
8.2%
7/85 • Number of events 32 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
9.6%
18/187 • Number of events 42 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
9.4%
8/85 • Number of events 43 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
3/187 • Number of events 15 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 11 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Flatulence
|
0.53%
1/187 • Number of events 9 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.2%
6/187 • Number of events 14 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
4.7%
4/85 • Number of events 12 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
3.7%
7/187 • Number of events 16 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 11 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.2%
6/187 • Number of events 11 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
4.7%
4/85 • Number of events 10 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
22.5%
42/187 • Number of events 101 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
22.4%
19/85 • Number of events 28 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Toothache
|
1.1%
2/187 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
8/187 • Number of events 16 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Chills
|
1.1%
2/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Edema face
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Edema limbs
|
2.1%
4/187 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Fatigue
|
59.4%
111/187 • Number of events 726 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
58.8%
50/85 • Number of events 347 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Fever
|
5.9%
11/187 • Number of events 16 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
12.9%
11/85 • Number of events 20 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Flu like symptoms
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Gen disord and admin site conds-Oth spec
|
5.3%
10/187 • Number of events 29 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
7.1%
6/85 • Number of events 19 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Injection site reaction
|
90.4%
169/187 • Number of events 1228 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
76.5%
65/85 • Number of events 412 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Localized edema
|
1.1%
2/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Malaise
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Neck edema
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
General disorders and administration site conditions
Pain
|
11.2%
21/187 • Number of events 46 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
11.8%
10/85 • Number of events 22 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Immune system disorders
Allergic reaction
|
6.4%
12/187 • Number of events 24 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
9.4%
8/85 • Number of events 11 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Immune system disorders
Autoimmune disorder
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Abdominal infection
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Bladder infection
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
7.5%
14/187 • Number of events 19 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
11.8%
10/85 • Number of events 12 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Nail infection
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 8 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Otitis media
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Papulopustular rash
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Pharyngitis
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Sepsis
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Sinusitis
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Skin infection
|
1.6%
3/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Upper respiratory infection
|
2.1%
4/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
4/187 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.1%
2/187 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Burn
|
1.1%
2/187 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
2/187 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Seroma
|
1.1%
2/187 • Number of events 12 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
13/187 • Number of events 41 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
11.8%
10/85 • Number of events 39 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Alkaline phosphatase increased
|
7.5%
14/187 • Number of events 55 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
10/187 • Number of events 22 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
8.2%
7/85 • Number of events 30 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Blood bilirubin increased
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Cholesterol high
|
2.1%
4/187 • Number of events 12 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Creatinine increased
|
5.3%
10/187 • Number of events 32 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
4.7%
4/85 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Hemoglobin increased
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Investigations - Other, specify
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Lymphocyte count decreased
|
22.5%
42/187 • Number of events 116 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
11.8%
10/85 • Number of events 24 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Lymphocyte count increased
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Neutrophil count decreased
|
7.5%
14/187 • Number of events 32 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
9.4%
8/85 • Number of events 22 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Platelet count decreased
|
5.3%
10/187 • Number of events 36 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
7.1%
6/85 • Number of events 16 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Weight gain
|
1.6%
3/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
5.9%
5/85 • Number of events 16 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
Weight loss
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Investigations
White blood cell decreased
|
26.7%
50/187 • Number of events 169 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
30.6%
26/85 • Number of events 68 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.6%
3/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 10 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.7%
5/187 • Number of events 15 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
8/187 • Number of events 15 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
2/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.6%
3/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.1%
2/187 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
3/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.1%
4/187 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.6%
3/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.8%
67/187 • Number of events 388 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
37.6%
32/85 • Number of events 217 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
3/187 • Number of events 17 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
15/187 • Number of events 106 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
10.6%
9/85 • Number of events 32 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.6%
3/187 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 8 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.53%
1/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.53%
1/187 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
8.6%
16/187 • Number of events 66 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.3%
53/187 • Number of events 260 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
30.6%
26/85 • Number of events 153 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
2/187 • Number of events 9 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 9 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.6%
3/187 • Number of events 14 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
12/187 • Number of events 31 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
4.7%
4/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
2.1%
4/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Cognitive disturbance
|
1.1%
2/187 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Dizziness
|
5.3%
10/187 • Number of events 17 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
8.2%
7/85 • Number of events 26 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Dysgeusia
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 9 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Encephalopathy
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Headache
|
17.6%
33/187 • Number of events 109 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
17.6%
15/85 • Number of events 45 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Memory impairment
|
2.1%
4/187 • Number of events 26 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 22 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Paresthesia
|
1.1%
2/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
12.8%
24/187 • Number of events 97 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
14.1%
12/85 • Number of events 45 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
42.8%
80/187 • Number of events 507 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
45.9%
39/85 • Number of events 322 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Nervous system disorders
Presyncope
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Anxiety
|
7.5%
14/187 • Number of events 86 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
5.9%
5/85 • Number of events 31 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Depression
|
1.1%
2/187 • Number of events 14 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Insomnia
|
2.7%
5/187 • Number of events 41 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 13 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Irritability
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.7%
5/187 • Number of events 14 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Psychiatric disorders
Restlessness
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Bladder spasm
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
2/187 • Number of events 12 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Hematuria
|
1.1%
2/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Proteinuria
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.1%
2/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Urinary fistula
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Urinary frequency
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
3/187 • Number of events 13 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Renal and urinary disorders
Urinary urgency
|
1.1%
2/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Reproductive system and breast disorders
Breast pain
|
3.2%
6/187 • Number of events 34 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
2.1%
4/187 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.53%
1/187 • Number of events 6 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.1%
2/187 • Number of events 9 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 17 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
14/187 • Number of events 25 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
7.1%
6/85 • Number of events 10 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
9/187 • Number of events 30 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.1%
4/187 • Number of events 8 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
3/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.53%
1/187 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 8 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.1%
4/187 • Number of events 5 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.53%
1/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.1%
2/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.2%
6/187 • Number of events 13 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
5.9%
5/85 • Number of events 20 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 14 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.53%
1/187 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
9/187 • Number of events 22 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
9.4%
8/85 • Number of events 24 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.2%
6/187 • Number of events 9 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
6/187 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
10.2%
19/187 • Number of events 52 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
7.1%
6/85 • Number of events 17 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.6%
3/187 • Number of events 10 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
3.5%
3/85 • Number of events 23 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
1.1%
2/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.7%
5/187 • Number of events 10 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.53%
1/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Flushing
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 7 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Hematoma
|
1.1%
2/187 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Hot flashes
|
7.0%
13/187 • Number of events 62 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
9.4%
8/85 • Number of events 55 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Hypertension
|
7.0%
13/187 • Number of events 54 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
7.1%
6/85 • Number of events 23 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Hypotension
|
0.53%
1/187 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
2.4%
2/85 • Number of events 4 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Lymphedema
|
3.2%
6/187 • Number of events 31 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 2 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.53%
1/187 • Number of events 3 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
0.00%
0/85 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/187 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
1.2%
1/85 • Number of events 1 • Adverse events assessed up to 5 years; all cause mortality assessed up to 7 years. Only patients that began treatment were assessed for adverse events; all enrolled patients were monitored for all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place