Trial Outcomes & Findings for Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma (NCT NCT04339738)
NCT ID: NCT04339738
Last Updated: 2026-05-07
Results Overview
ORR defined as count of participants that reported a confirmed best response of partial response (PR) or complete response (CR). Evaluation of disease response determination will be defined based on RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Each target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
1.5 years
Results posted on
2026-05-07
Participant Flow
Participant milestones
| Measure |
Arm I (Nivolumab, Paclitaxel)
Patients receive nivolumab IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Nivolumab: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Paclitaxel: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
For a patient on paclitaxel, once they are deemed by their local physician to have progressive disease per RECIST 1.1, they may cross-over to receive cabozantinib + nivolumab.
|
Arm III (Nivolumab, Cabozantinib S-malate)
Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Cabozantinib S-malate: Given PO
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Nivolumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Initial Treatment
STARTED
|
32
|
35
|
23
|
|
Initial Treatment
COMPLETED
|
0
|
0
|
3
|
|
Initial Treatment
NOT COMPLETED
|
32
|
35
|
20
|
|
Crossover Treatment
STARTED
|
0
|
9
|
0
|
|
Crossover Treatment
COMPLETED
|
0
|
0
|
0
|
|
Crossover Treatment
NOT COMPLETED
|
0
|
9
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Nivolumab, Paclitaxel)
Patients receive nivolumab IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Nivolumab: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Paclitaxel: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
For a patient on paclitaxel, once they are deemed by their local physician to have progressive disease per RECIST 1.1, they may cross-over to receive cabozantinib + nivolumab.
|
Arm III (Nivolumab, Cabozantinib S-malate)
Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Cabozantinib S-malate: Given PO
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Nivolumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Initial Treatment
Patient withdrawal prior to beginning treatment
|
0
|
2
|
0
|
|
Initial Treatment
Withdrawn due to ineligibility prior to beginning treatment
|
1
|
0
|
1
|
|
Initial Treatment
Disease progression
|
16
|
15
|
16
|
|
Initial Treatment
Physician Decision
|
2
|
2
|
1
|
|
Initial Treatment
Adverse Event
|
1
|
3
|
0
|
|
Initial Treatment
Withdrawal by Subject
|
1
|
3
|
0
|
|
Initial Treatment
On active treatment
|
11
|
5
|
1
|
|
Initial Treatment
Death
|
0
|
2
|
0
|
|
Initial Treatment
Complicating disease
|
0
|
1
|
0
|
|
Initial Treatment
Patient and physician decision
|
0
|
1
|
0
|
|
Initial Treatment
Clinical progression
|
0
|
1
|
0
|
|
Initial Treatment
Alternative therapy
|
0
|
0
|
1
|
|
Crossover Treatment
Disease progression
|
0
|
4
|
0
|
|
Crossover Treatment
Adverse Event
|
0
|
2
|
0
|
|
Crossover Treatment
Physician Decision
|
0
|
1
|
0
|
|
Crossover Treatment
On active treatment
|
0
|
2
|
0
|
Baseline Characteristics
Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Arm I (Nivolumab, Paclitaxel)
n=31 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.\> \> Biospecimen Collection: Undergo collection of blood\>
\> Computed Tomography: Undergo CT, spiral CT\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Nivolumab: Given IV\>
\> Paclitaxel: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Paclitaxel)
n=33 Participants
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.\>
\> Biospecimen Collection: Undergo collection of blood\>
\> Computed Tomography: Undergo CT, spiral CT\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Paclitaxel: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm III (Nivolumab, Cabozantinib S-malate)
n=22 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.\> \> Biospecimen Collection: Undergo collection of blood\>
\> Cabozantinib S-malate: Given PO\>
\> Computed Tomography: Undergo CT, spiral CT\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Nivolumab: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 15.83 • n=54 Participants
|
67.7 years
STANDARD_DEVIATION 10.81 • n=60 Participants
|
65.0 years
STANDARD_DEVIATION 14.03 • n=114 Participants
|
65.7 years
STANDARD_DEVIATION 13.55 • n=318 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=54 Participants
|
12 Participants
n=60 Participants
|
11 Participants
n=114 Participants
|
41 Participants
n=318 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=54 Participants
|
21 Participants
n=60 Participants
|
11 Participants
n=114 Participants
|
45 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
7 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=54 Participants
|
29 Participants
n=60 Participants
|
20 Participants
n=114 Participants
|
75 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
4 Participants
n=318 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
4 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
9 Participants
n=318 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=54 Participants
|
28 Participants
n=60 Participants
|
19 Participants
n=114 Participants
|
70 Participants
n=318 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
3 Participants
n=318 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=54 Participants
|
33 participants
n=60 Participants
|
22 participants
n=114 Participants
|
86 participants
n=318 Participants
|
PRIMARY outcome
Timeframe: 21 monthsPopulation: Analysis only includes patients in arm I and arm II, as protocol specified
Will compare the PFS in taxane naive angiosarcoma patients receiving either (1) paclitaxel + nivolumab compared to (2) paclitaxel alone. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions compared to the nadir (smallest) sum of target lesions, any new lesions, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Arm I (Nivolumab, Paclitaxel)
n=31 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Nivolumab: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Paclitaxel)
n=33 Participants
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Paclitaxel: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm III (Nivolumab, Cabozantinib S-malate)
Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Cabozantinib S-malate: Given PO
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Nivolumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Progression Free Survival (PFS) in Taxane Naive Patients With Angiosarcoma
|
5.6 months
Interval 4.3 to
Upper limit of confidence interval not estimable due to low number of events
|
8.3 months
Interval 5.1 to
Upper limit of confidence interval not estimable due to low number of events
|
—
|
PRIMARY outcome
Timeframe: 1.5 yearsPopulation: Analysis only conducted on Arm III patients, as protocol specified
ORR defined as count of participants that reported a confirmed best response of partial response (PR) or complete response (CR). Evaluation of disease response determination will be defined based on RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Each target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm I (Nivolumab, Paclitaxel)
Patients receive nivolumab IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Nivolumab: Given IV
\>
\> Paclitaxel: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Paclitaxel: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm III (Nivolumab, Cabozantinib S-malate)
n=22 Participants
Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood
\>
\> Cabozantinib S-malate: Given PO
\>
\> Computed Tomography: Undergo CT, spiral CT
\>
\> FDG-Positron Emission Tomography: Undergo FDG-PET
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Nivolumab: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Overall Response Rate (ORR) in Angiosarcoma Patients Who Have Had Prior Taxane
|
—
|
—
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsWill be estimated by dividing the number of evaluable patients that achieve a confirmed response by the total number of evaluable patients in the nivolumab + paclitaxel combination arm. Additionally a 95% confidence interval will be constructed utilizing properties of the binomial distribution.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study enrollment until death due to any cause, assessed up to 3 yearsWill be evaluated using the Kaplan-Meier method in order to determine the median survival rate. This median survival rate will be calculated for each of the 2 combination arms (i.e. nivolumab + paclitaxel and nivolumab + cabozantinib).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 monthsA patient will be declared an event for this endpoint if they had documented progression (or death) prior to, or at, their 6 month evaluation. This endpoint will be applied to the patients on the nivolumab + cabozantinib combination arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsMaximum grade adverse events will be summarized by treatment arm in a tabular setting. This will be done both with and without regard to the assigned attribution of each adverse event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsWill be assessed via PRO-Common Terminology Criteria for Adverse Events (CTCAE). In order to evaluate this endpoint we will calculate the proportion of patients that report a grade 3+ event along with a 95% confidence interval based on the properties of the binomial distribution. Any other analyses with these data will be done in an exploratory and hypothesis generating manner.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Nivolumab, Paclitaxel)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Arm II (Paclitaxel)
Serious events: 2 serious events
Other events: 22 other events
Deaths: 2 deaths
Arm III (Nivolumab, Cabozantinib S-malate)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 2 deaths
Crossover From Arm II
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Nivolumab, Paclitaxel)
n=31 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm II (Paclitaxel)
n=33 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm III (Nivolumab, Cabozantinib S-malate)
n=22 participants at risk
Questionnaire Administration: Ancillary studies
|
Crossover From Arm II
n=9 participants at risk
Crossover nivolumab + cabozantinib following PD on paclitaxel
|
|---|---|---|---|---|
|
General disorders
Death NOS
|
0.00%
0/31 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
Other adverse events
| Measure |
Arm I (Nivolumab, Paclitaxel)
n=31 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm II (Paclitaxel)
n=33 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm III (Nivolumab, Cabozantinib S-malate)
n=22 participants at risk
Questionnaire Administration: Ancillary studies
|
Crossover From Arm II
n=9 participants at risk
Crossover nivolumab + cabozantinib following PD on paclitaxel
|
|---|---|---|---|---|
|
Infections and infestations
Shingles
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 19 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Infections and infestations
Thrush
|
6.5%
2/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
6.5%
2/31 • Number of events 3 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
9.1%
2/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
3.2%
1/31 • Number of events 15 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 6 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
2/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
9.1%
2/22 • Number of events 3 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
6.5%
2/31 • Number of events 7 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.7%
3/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
3.2%
1/31 • Number of events 1 • 3 years
|
3.0%
1/33 • Number of events 5 • 3 years
|
9.1%
2/22 • Number of events 8 • 3 years
|
0.00%
0/9 • 3 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 8 • 3 years
|
4.5%
1/22 • Number of events 7 • 3 years
|
11.1%
1/9 • Number of events 6 • 3 years
|
|
Investigations
Activated partial throm time prolonged
|
6.5%
2/31 • Number of events 5 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
25.8%
8/31 • Number of events 12 • 3 years
|
12.1%
4/33 • Number of events 6 • 3 years
|
31.8%
7/22 • Number of events 23 • 3 years
|
55.6%
5/9 • Number of events 23 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
29.0%
9/31 • Number of events 25 • 3 years
|
6.1%
2/33 • Number of events 12 • 3 years
|
18.2%
4/22 • Number of events 25 • 3 years
|
66.7%
6/9 • Number of events 16 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
22.6%
7/31 • Number of events 15 • 3 years
|
12.1%
4/33 • Number of events 22 • 3 years
|
40.9%
9/22 • Number of events 35 • 3 years
|
55.6%
5/9 • Number of events 19 • 3 years
|
|
Investigations
Blood bilirubin increased
|
3.2%
1/31 • Number of events 1 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
0.00%
0/22 • 3 years
|
33.3%
3/9 • Number of events 14 • 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.2%
1/31 • Number of events 1 • 3 years
|
3.0%
1/33 • Number of events 18 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Investigations
Cholesterol high
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 4 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Investigations
Creatinine increased
|
16.1%
5/31 • Number of events 10 • 3 years
|
6.1%
2/33 • Number of events 12 • 3 years
|
9.1%
2/22 • Number of events 3 • 3 years
|
22.2%
2/9 • Number of events 6 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
19.4%
6/31 • Number of events 31 • 3 years
|
21.2%
7/33 • Number of events 27 • 3 years
|
31.8%
7/22 • Number of events 43 • 3 years
|
33.3%
3/9 • Number of events 16 • 3 years
|
|
Investigations
Lymphocyte count increased
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 2 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Investigations
Neutrophil count decreased
|
22.6%
7/31 • Number of events 20 • 3 years
|
15.2%
5/33 • Number of events 7 • 3 years
|
13.6%
3/22 • Number of events 3 • 3 years
|
66.7%
6/9 • Number of events 12 • 3 years
|
|
Investigations
Platelet count decreased
|
9.7%
3/31 • Number of events 5 • 3 years
|
9.1%
3/33 • Number of events 7 • 3 years
|
13.6%
3/22 • Number of events 4 • 3 years
|
66.7%
6/9 • Number of events 18 • 3 years
|
|
Investigations
Thyroid stimulating hormone increased
|
6.5%
2/31 • Number of events 4 • 3 years
|
0.00%
0/33 • 3 years
|
18.2%
4/22 • Number of events 13 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Investigations
Weight gain
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 26 • 3 years
|
0.00%
0/9 • 3 years
|
|
Investigations
Weight loss
|
16.1%
5/31 • Number of events 34 • 3 years
|
6.1%
2/33 • Number of events 6 • 3 years
|
40.9%
9/22 • Number of events 71 • 3 years
|
11.1%
1/9 • Number of events 3 • 3 years
|
|
Investigations
White blood cell decreased
|
29.0%
9/31 • Number of events 26 • 3 years
|
21.2%
7/33 • Number of events 27 • 3 years
|
22.7%
5/22 • Number of events 15 • 3 years
|
55.6%
5/9 • Number of events 15 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
41.9%
13/31 • Number of events 56 • 3 years
|
18.2%
6/33 • Number of events 33 • 3 years
|
50.0%
11/22 • Number of events 92 • 3 years
|
44.4%
4/9 • Number of events 16 • 3 years
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/31 • 3 years
|
12.1%
4/33 • Number of events 4 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.2%
1/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 4 • 3 years
|
0.00%
0/9 • 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.2%
1/31 • Number of events 2 • 3 years
|
9.1%
3/33 • Number of events 3 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.3%
10/31 • Number of events 40 • 3 years
|
18.2%
6/33 • Number of events 27 • 3 years
|
27.3%
6/22 • Number of events 31 • 3 years
|
77.8%
7/9 • Number of events 37 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.2%
1/31 • Number of events 1 • 3 years
|
9.1%
3/33 • Number of events 7 • 3 years
|
13.6%
3/22 • Number of events 4 • 3 years
|
22.2%
2/9 • Number of events 6 • 3 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.5%
2/31 • Number of events 6 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.7%
3/31 • Number of events 7 • 3 years
|
9.1%
3/33 • Number of events 10 • 3 years
|
18.2%
4/22 • Number of events 12 • 3 years
|
33.3%
3/9 • Number of events 16 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.1%
5/31 • Number of events 19 • 3 years
|
6.1%
2/33 • Number of events 5 • 3 years
|
13.6%
3/22 • Number of events 6 • 3 years
|
33.3%
3/9 • Number of events 12 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 2 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
2/31 • Number of events 6 • 3 years
|
12.1%
4/33 • Number of events 7 • 3 years
|
31.8%
7/22 • Number of events 12 • 3 years
|
33.3%
3/9 • Number of events 14 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.4%
6/31 • Number of events 12 • 3 years
|
12.1%
4/33 • Number of events 22 • 3 years
|
18.2%
4/22 • Number of events 6 • 3 years
|
44.4%
4/9 • Number of events 11 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
27.3%
6/22 • Number of events 66 • 3 years
|
11.1%
1/9 • Number of events 6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 3 • 3 years
|
9.1%
2/22 • Number of events 16 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • Number of events 20 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
22.7%
5/22 • Number of events 50 • 3 years
|
22.2%
2/9 • Number of events 4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.5%
2/31 • Number of events 2 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.2%
1/31 • Number of events 4 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.2%
1/31 • Number of events 14 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 5 • 3 years
|
22.2%
2/9 • Number of events 6 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 3 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.2%
1/31 • Number of events 4 • 3 years
|
6.1%
2/33 • Number of events 4 • 3 years
|
9.1%
2/22 • Number of events 3 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
3.2%
1/31 • Number of events 2 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
3.2%
1/31 • Number of events 1 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
18.2%
4/22 • Number of events 68 • 3 years
|
11.1%
1/9 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.2%
1/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 19 • 3 years
|
4.5%
1/22 • Number of events 5 • 3 years
|
0.00%
0/9 • 3 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Corneal infection
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
12.9%
4/31 • Number of events 6 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
13.6%
3/22 • Number of events 10 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Lung infection
|
6.5%
2/31 • Number of events 2 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
0.00%
0/22 • 3 years
|
22.2%
2/9 • Number of events 4 • 3 years
|
|
Infections and infestations
Nail infection
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Infections and infestations
Paronychia
|
3.2%
1/31 • Number of events 8 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.5%
2/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
32.3%
10/31 • Number of events 53 • 3 years
|
24.2%
8/33 • Number of events 43 • 3 years
|
45.5%
10/22 • Number of events 55 • 3 years
|
22.2%
2/9 • Number of events 4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
11.1%
1/9 • Number of events 5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
12.9%
4/31 • Number of events 11 • 3 years
|
9.1%
3/33 • Number of events 4 • 3 years
|
31.8%
7/22 • Number of events 39 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 3 • 3 years
|
11.1%
1/9 • Number of events 6 • 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Vascular disorders
Arterial thromboembolism
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 4 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Vascular disorders
Capillary leak syndrome
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Vascular disorders
Flushing
|
3.2%
1/31 • Number of events 1 • 3 years
|
6.1%
2/33 • Number of events 6 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Vascular disorders
Hot flashes
|
9.7%
3/31 • Number of events 6 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Vascular disorders
Hypertension
|
51.6%
16/31 • Number of events 148 • 3 years
|
42.4%
14/33 • Number of events 87 • 3 years
|
86.4%
19/22 • Number of events 189 • 3 years
|
77.8%
7/9 • Number of events 29 • 3 years
|
|
Vascular disorders
Hypotension
|
12.9%
4/31 • Number of events 5 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
9.1%
2/22 • Number of events 10 • 3 years
|
22.2%
2/9 • Number of events 12 • 3 years
|
|
Vascular disorders
Lymphedema
|
3.2%
1/31 • Number of events 1 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
6.5%
2/31 • Number of events 2 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
13.6%
3/22 • Number of events 20 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/31 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 3 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
3.2%
1/31 • Number of events 12 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
9.7%
3/31 • Number of events 31 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
13.6%
3/22 • Number of events 23 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.0%
9/31 • Number of events 32 • 3 years
|
15.2%
5/33 • Number of events 19 • 3 years
|
36.4%
8/22 • Number of events 69 • 3 years
|
22.2%
2/9 • Number of events 4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.5%
2/31 • Number of events 15 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 5 • 3 years
|
0.00%
0/9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.6%
7/31 • Number of events 67 • 3 years
|
3.0%
1/33 • Number of events 4 • 3 years
|
22.7%
5/22 • Number of events 19 • 3 years
|
22.2%
2/9 • Number of events 15 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
3.2%
1/31 • Number of events 4 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 7 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.2%
1/31 • Number of events 6 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
13.6%
3/22 • Number of events 10 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Anosmia
|
3.2%
1/31 • Number of events 2 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 3 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Concentration impairment
|
3.2%
1/31 • Number of events 1 • 3 years
|
6.1%
2/33 • Number of events 7 • 3 years
|
4.5%
1/22 • Number of events 24 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Dizziness
|
9.7%
3/31 • Number of events 11 • 3 years
|
6.1%
2/33 • Number of events 5 • 3 years
|
18.2%
4/22 • Number of events 70 • 3 years
|
22.2%
2/9 • Number of events 2 • 3 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 4 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 6 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
19.4%
6/31 • Number of events 45 • 3 years
|
3.0%
1/33 • Number of events 7 • 3 years
|
22.7%
5/22 • Number of events 39 • 3 years
|
22.2%
2/9 • Number of events 4 • 3 years
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • Number of events 26 • 3 years
|
6.1%
2/33 • Number of events 8 • 3 years
|
31.8%
7/22 • Number of events 28 • 3 years
|
22.2%
2/9 • Number of events 3 • 3 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Memory impairment
|
3.2%
1/31 • Number of events 4 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 5 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 3 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 10 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Paresthesia
|
6.5%
2/31 • Number of events 10 • 3 years
|
3.0%
1/33 • Number of events 4 • 3 years
|
0.00%
0/22 • 3 years
|
22.2%
2/9 • Number of events 3 • 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.7%
3/31 • Number of events 17 • 3 years
|
12.1%
4/33 • Number of events 25 • 3 years
|
27.3%
6/22 • Number of events 106 • 3 years
|
22.2%
2/9 • Number of events 37 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
48.4%
15/31 • Number of events 159 • 3 years
|
42.4%
14/33 • Number of events 101 • 3 years
|
50.0%
11/22 • Number of events 119 • 3 years
|
77.8%
7/9 • Number of events 62 • 3 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Nervous system disorders
Syncope
|
3.2%
1/31 • Number of events 1 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Number of events 18 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
18.2%
4/22 • Number of events 23 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Psychiatric disorders
Depression
|
9.7%
3/31 • Number of events 8 • 3 years
|
6.1%
2/33 • Number of events 9 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Psychiatric disorders
Hallucinations
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Psychiatric disorders
Insomnia
|
19.4%
6/31 • Number of events 24 • 3 years
|
9.1%
3/33 • Number of events 6 • 3 years
|
9.1%
2/22 • Number of events 8 • 3 years
|
0.00%
0/9 • 3 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/31 • 3 years
|
6.1%
2/33 • Number of events 3 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
3.2%
1/31 • Number of events 2 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
3.2%
1/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
22.2%
2/9 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Glucosuria
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 3 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 5 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 6 • 3 years
|
13.6%
3/22 • Number of events 8 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 3 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
6.5%
2/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
1/31 • Number of events 4 • 3 years
|
3.0%
1/33 • Number of events 4 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.2%
1/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 3 • 3 years
|
0.00%
0/9 • 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
3.2%
1/31 • Number of events 4 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.2%
1/31 • Number of events 10 • 3 years
|
6.1%
2/33 • Number of events 9 • 3 years
|
9.1%
2/22 • Number of events 30 • 3 years
|
0.00%
0/9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.9%
13/31 • Number of events 72 • 3 years
|
39.4%
13/33 • Number of events 48 • 3 years
|
54.5%
12/22 • Number of events 74 • 3 years
|
55.6%
5/9 • Number of events 18 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.5%
11/31 • Number of events 69 • 3 years
|
33.3%
11/33 • Number of events 57 • 3 years
|
54.5%
12/22 • Number of events 62 • 3 years
|
66.7%
6/9 • Number of events 31 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
2/31 • Number of events 4 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.2%
1/31 • Number of events 1 • 3 years
|
9.1%
3/33 • Number of events 3 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.2%
1/31 • Number of events 16 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
18.2%
4/22 • Number of events 52 • 3 years
|
11.1%
1/9 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.5%
2/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 8 • 3 years
|
0.00%
0/9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.9%
4/31 • Number of events 9 • 3 years
|
9.1%
3/33 • Number of events 7 • 3 years
|
18.2%
4/22 • Number of events 6 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.5%
2/31 • Number of events 2 • 3 years
|
0.00%
0/33 • 3 years
|
18.2%
4/22 • Number of events 5 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.2%
1/31 • Number of events 3 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
6.5%
2/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 3 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 9 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.2%
1/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
9.1%
2/22 • Number of events 9 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 4 • 3 years
|
0.00%
0/9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.2%
1/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.1%
18/31 • Number of events 131 • 3 years
|
45.5%
15/33 • Number of events 103 • 3 years
|
54.5%
12/22 • Number of events 96 • 3 years
|
55.6%
5/9 • Number of events 42 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.1%
5/31 • Number of events 27 • 3 years
|
12.1%
4/33 • Number of events 7 • 3 years
|
13.6%
3/22 • Number of events 26 • 3 years
|
33.3%
3/9 • Number of events 17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
2/31 • Number of events 8 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
9.1%
2/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
9.7%
3/31 • Number of events 40 • 3 years
|
3.0%
1/33 • Number of events 8 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.2%
1/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 8 • 3 years
|
0.00%
0/9 • 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
9.7%
3/31 • Number of events 7 • 3 years
|
3.0%
1/33 • Number of events 6 • 3 years
|
27.3%
6/22 • Number of events 81 • 3 years
|
33.3%
3/9 • Number of events 12 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.3%
10/31 • Number of events 66 • 3 years
|
18.2%
6/33 • Number of events 11 • 3 years
|
31.8%
7/22 • Number of events 16 • 3 years
|
66.7%
6/9 • Number of events 19 • 3 years
|
|
General disorders
Edema limbs
|
32.3%
10/31 • Number of events 51 • 3 years
|
21.2%
7/33 • Number of events 36 • 3 years
|
27.3%
6/22 • Number of events 73 • 3 years
|
33.3%
3/9 • Number of events 16 • 3 years
|
|
General disorders
Facial pain
|
3.2%
1/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 4 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Fatigue
|
67.7%
21/31 • Number of events 195 • 3 years
|
51.5%
17/33 • Number of events 125 • 3 years
|
81.8%
18/22 • Number of events 163 • 3 years
|
100.0%
9/9 • Number of events 92 • 3 years
|
|
General disorders
Fever
|
12.9%
4/31 • Number of events 6 • 3 years
|
6.1%
2/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Gait disturbance
|
0.00%
0/31 • 3 years
|
9.1%
3/33 • Number of events 25 • 3 years
|
4.5%
1/22 • Number of events 7 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
3.2%
1/31 • Number of events 16 • 3 years
|
6.1%
2/33 • Number of events 6 • 3 years
|
4.5%
1/22 • Number of events 8 • 3 years
|
11.1%
1/9 • Number of events 7 • 3 years
|
|
General disorders
Generalized edema
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Infusion site extravasation
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Localized edema
|
6.5%
2/31 • Number of events 2 • 3 years
|
6.1%
2/33 • Number of events 8 • 3 years
|
9.1%
2/22 • Number of events 6 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Malaise
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 4 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
6.5%
2/31 • Number of events 4 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 8 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Pain
|
12.9%
4/31 • Number of events 8 • 3 years
|
3.0%
1/33 • Number of events 9 • 3 years
|
22.7%
5/22 • Number of events 7 • 3 years
|
33.3%
3/9 • Number of events 7 • 3 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
6.5%
2/31 • Number of events 5 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 9 • 3 years
|
0.00%
0/9 • 3 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Aortic valve disease
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • 3 years
|
3.0%
1/33 • Number of events 8 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 39 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
6.5%
2/31 • Number of events 2 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Palpitations
|
3.2%
1/31 • Number of events 2 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Pericardial tamponade
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
9.7%
3/31 • Number of events 3 • 3 years
|
6.1%
2/33 • Number of events 4 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 3 • 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 3 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.2%
1/31 • Number of events 4 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 3 • 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
6.5%
2/31 • Number of events 27 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 3 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Endocrine disorders
Hypothyroidism
|
12.9%
4/31 • Number of events 10 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
36.4%
8/22 • Number of events 79 • 3 years
|
44.4%
4/9 • Number of events 11 • 3 years
|
|
Eye disorders
Blurred vision
|
6.5%
2/31 • Number of events 6 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
13.6%
3/22 • Number of events 13 • 3 years
|
0.00%
0/9 • 3 years
|
|
Eye disorders
Cataract
|
3.2%
1/31 • Number of events 6 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 39 • 3 years
|
0.00%
0/9 • 3 years
|
|
Eye disorders
Dry eye
|
6.5%
2/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Eye disorders
Eye disorders - Other, specify
|
3.2%
1/31 • Number of events 19 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
4.5%
1/22 • Number of events 6 • 3 years
|
0.00%
0/9 • 3 years
|
|
Eye disorders
Eye pain
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Eye disorders
Floaters
|
3.2%
1/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Eye disorders
Periorbital edema
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Eye disorders
Uveitis
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Eye disorders
Watering eyes
|
3.2%
1/31 • Number of events 1 • 3 years
|
3.0%
1/33 • Number of events 7 • 3 years
|
4.5%
1/22 • Number of events 52 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • 3 years
|
12.1%
4/33 • Number of events 6 • 3 years
|
9.1%
2/22 • Number of events 4 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Cheilitis
|
3.2%
1/31 • Number of events 7 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
45.2%
14/31 • Number of events 99 • 3 years
|
42.4%
14/33 • Number of events 56 • 3 years
|
45.5%
10/22 • Number of events 102 • 3 years
|
88.9%
8/9 • Number of events 43 • 3 years
|
|
Gastrointestinal disorders
Dental caries
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
48.4%
15/31 • Number of events 70 • 3 years
|
15.2%
5/33 • Number of events 16 • 3 years
|
63.6%
14/22 • Number of events 156 • 3 years
|
100.0%
9/9 • Number of events 36 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
12.9%
4/31 • Number of events 48 • 3 years
|
6.1%
2/33 • Number of events 5 • 3 years
|
22.7%
5/22 • Number of events 28 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/31 • 3 years
|
6.1%
2/33 • Number of events 4 • 3 years
|
4.5%
1/22 • Number of events 17 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
9.1%
2/22 • Number of events 5 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
1/31 • Number of events 16 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
3.2%
1/31 • Number of events 1 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.5%
2/31 • Number of events 12 • 3 years
|
0.00%
0/33 • 3 years
|
13.6%
3/22 • Number of events 37 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
6.5%
2/31 • Number of events 3 • 3 years
|
9.1%
3/33 • Number of events 5 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.2%
1/31 • Number of events 4 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
9.7%
3/31 • Number of events 7 • 3 years
|
9.1%
3/33 • Number of events 6 • 3 years
|
27.3%
6/22 • Number of events 27 • 3 years
|
11.1%
1/9 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
29.0%
9/31 • Number of events 21 • 3 years
|
18.2%
6/33 • Number of events 26 • 3 years
|
45.5%
10/22 • Number of events 126 • 3 years
|
22.2%
2/9 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 6 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
6.5%
2/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 3 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Periodontal disease
|
3.2%
1/31 • Number of events 3 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
3.2%
1/31 • Number of events 2 • 3 years
|
0.00%
0/33 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • 3 years
|
0.00%
0/33 • 3 years
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/9 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
2/31 • Number of events 7 • 3 years
|
12.1%
4/33 • Number of events 8 • 3 years
|
36.4%
8/22 • Number of events 13 • 3 years
|
11.1%
1/9 • Number of events 2 • 3 years
|
|
General disorders
Chills
|
9.7%
3/31 • Number of events 3 • 3 years
|
6.1%
2/33 • Number of events 4 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Disease progression
|
0.00%
0/31 • 3 years
|
3.0%
1/33 • Number of events 1 • 3 years
|
0.00%
0/22 • 3 years
|
0.00%
0/9 • 3 years
|
|
General disorders
Edema face
|
0.00%
0/31 • 3 years
|
9.1%
3/33 • Number of events 5 • 3 years
|
0.00%
0/22 • 3 years
|
22.2%
2/9 • Number of events 4 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
64.5%
20/31 • Number of events 166 • 3 years
|
45.5%
15/33 • Number of events 119 • 3 years
|
68.2%
15/22 • Number of events 97 • 3 years
|
100.0%
9/9 • Number of events 94 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
6.5%
2/31 • Number of events 2 • 3 years
|
3.0%
1/33 • Number of events 2 • 3 years
|
0.00%
0/22 • 3 years
|
11.1%
1/9 • Number of events 5 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60