Trial Outcomes & Findings for Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT02446600)
NCT ID: NCT02446600
Last Updated: 2025-12-01
Results Overview
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
579 participants
Primary outcome timeframe
The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.
Results posted on
2025-12-01
Participant Flow
Study opened for accrual February 4th, 2016. Accrual to the randomized component of this study stopped on November 13, 2017 after enrolling 579 patients. One enrollment was a duplicate, so data is reported for 578 subjects.
Participant milestones
| Measure |
Arm I (Platinum-based Chemotherapy)
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm II (Olaparib)
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
187
|
190
|
189
|
13
|
|
Overall Study
COMPLETED
|
147
|
178
|
162
|
12
|
|
Overall Study
NOT COMPLETED
|
40
|
12
|
27
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Platinum-based Chemotherapy)
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm II (Olaparib)
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
|---|---|---|---|---|
|
Overall Study
Never treated
|
20
|
2
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
19
|
5
|
17
|
0
|
|
Overall Study
Ineligible
|
1
|
4
|
4
|
1
|
|
Overall Study
Duplicate Enrollment
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Platinum-based Chemotherapy)
n=187 Participants
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm II (Olaparib)
n=189 Participants
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
n=189 Participants
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
n=13 Participants
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
Total
n=578 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 10.0 • n=121 Participants
|
64.6 years
STANDARD_DEVIATION 10.0 • n=122 Participants
|
64.0 years
STANDARD_DEVIATION 9.8 • n=243 Participants
|
58.6 years
STANDARD_DEVIATION 8.3 • n=24 Participants
|
62.6 years
STANDARD_DEVIATION 9.5 • n=8 Participants
|
|
Age, Customized
Less than 40 years
|
4 Participants
n=121 Participants
|
3 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=8 Participants
|
|
Age, Customized
40-49 years
|
10 Participants
n=121 Participants
|
11 Participants
n=122 Participants
|
13 Participants
n=243 Participants
|
2 Participants
n=24 Participants
|
36 Participants
n=8 Participants
|
|
Age, Customized
50-59 years
|
53 Participants
n=121 Participants
|
48 Participants
n=122 Participants
|
52 Participants
n=243 Participants
|
5 Participants
n=24 Participants
|
158 Participants
n=8 Participants
|
|
Age, Customized
60-69 years
|
74 Participants
n=121 Participants
|
63 Participants
n=122 Participants
|
71 Participants
n=243 Participants
|
5 Participants
n=24 Participants
|
213 Participants
n=8 Participants
|
|
Age, Customized
>= 70 years
|
46 Participants
n=121 Participants
|
64 Participants
n=122 Participants
|
52 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
163 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=121 Participants
|
189 Participants
n=122 Participants
|
189 Participants
n=243 Participants
|
13 Participants
n=24 Participants
|
578 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
171 Participants
n=121 Participants
|
184 Participants
n=122 Participants
|
177 Participants
n=243 Participants
|
13 Participants
n=24 Participants
|
545 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=121 Participants
|
3 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=121 Participants
|
8 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
13 Participants
n=24 Participants
|
32 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
4 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=121 Participants
|
7 Participants
n=122 Participants
|
8 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
164 Participants
n=121 Participants
|
161 Participants
n=122 Participants
|
163 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
488 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=121 Participants
|
8 Participants
n=122 Participants
|
8 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
24 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.Population: All Randomized subjects
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments.
Outcome measures
| Measure |
Arm II (Olaparib)
n=189 Participants
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
n=189 Participants
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm I (Platinum-based Chemotherapy)
n=187 Participants
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
|---|---|---|---|---|
|
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
|
8.2 months
Interval 6.6 to 8.7
|
10.4 months
Interval 8.5 to 12.5
|
10.3 months
Interval 8.7 to 11.2
|
—
|
SECONDARY outcome
Timeframe: Approximately 30 monthsPopulation: All randomized subjects
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Japanese cohort not included in overall survival analysis, the cohort was only included in toxicity assessments.
Outcome measures
| Measure |
Arm II (Olaparib)
n=189 Participants
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
n=189 Participants
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm I (Platinum-based Chemotherapy)
n=187 Participants
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
|---|---|---|---|---|
|
Overall Survival
|
29.2 months
Interval 23.9 to 32.7
|
30.5 months
Interval 27.0 to 36.5
|
31.3 months
Interval 26.4 to 34.4
|
—
|
SECONDARY outcome
Timeframe: During treatment period and up to 100 days after stopping the study treatment, up to 39 months.Population: Treated with randomized therapy.
Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy, by Preferred term with incidence rate greater than 5%.
Outcome measures
| Measure |
Arm II (Olaparib)
n=188 Participants
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
n=188 Participants
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm I (Platinum-based Chemotherapy)
n=171 Participants
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
n=13 Participants
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
|---|---|---|---|---|
|
Frequency and Severity of Adverse Effects
Anemia
|
28 Participants
|
11 Participants
|
23 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Effects
Fatigue
|
12 Participants
|
31 Participants
|
3 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects
Neutrophil count decreased
|
3 Participants
|
7 Participants
|
51 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Effects
Platelet count decreased
|
2 Participants
|
3 Participants
|
24 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects
Urinary tract infection
|
11 Participants
|
15 Participants
|
10 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects
White blood cell decreased
|
3 Participants
|
2 Participants
|
22 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Prior to cycle 1, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and 108 weeks after starting treatmentPopulation: Subjects who have completed baseline and at least one follow-up assessment.
Disease-related physical symptoms were measured by the Disease-Related Symptom-Physical (DRS-P) subscale of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NCCN/FOSI-18). The DRS-P subscale is composed of 9 items. For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The DRS-P score ranges 0-36 with a larger score suggesting better QOL (Quality of Life) or less symptoms. This analysis did not include the Japanese cohort.
Outcome measures
| Measure |
Arm II (Olaparib)
n=171 Participants
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
n=167 Participants
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm I (Platinum-based Chemotherapy)
n=151 Participants
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
|---|---|---|---|---|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
Baseline
|
17.8 score on a scale
Standard Deviation 2.7
|
17.9 score on a scale
Standard Deviation 2.5
|
17.1 score on a scale
Standard Deviation 3.0
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
12 Weeks
|
17.4 score on a scale
Standard Deviation 2.4
|
15.9 score on a scale
Standard Deviation 3.0
|
16.5 score on a scale
Standard Deviation 2.8
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
24 Weeks
|
17.4 score on a scale
Standard Deviation 2.8
|
16.3 score on a scale
Standard Deviation 2.9
|
16.3 score on a scale
Standard Deviation 3.0
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
36 Weeks
|
17.2 score on a scale
Standard Deviation 3.0
|
16.3 score on a scale
Standard Deviation 2.7
|
16.9 score on a scale
Standard Deviation 3.0
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
48 Weeks
|
17.1 score on a scale
Standard Deviation 2.6
|
16.5 score on a scale
Standard Deviation 2.7
|
16.9 score on a scale
Standard Deviation 3.9
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
60 Weeks
|
16.9 score on a scale
Standard Deviation 3.0
|
16.3 score on a scale
Standard Deviation 2.7
|
16.5 score on a scale
Standard Deviation 3.6
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
72 Weeks
|
17.3 score on a scale
Standard Deviation 2.7
|
16.3 score on a scale
Standard Deviation 3.2
|
17.1 score on a scale
Standard Deviation 2.9
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
84 Weeks
|
17.2 score on a scale
Standard Deviation 2.8
|
16.6 score on a scale
Standard Deviation 2.7
|
17.4 score on a scale
Standard Deviation 2.9
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
96 Weeks
|
16.9 score on a scale
Standard Deviation 2.6
|
17.0 score on a scale
Standard Deviation 2.9
|
17.0 score on a scale
Standard Deviation 3.0
|
—
|
|
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
108 Weeks
|
17.4 score on a scale
Standard Deviation 2.3
|
17.2 score on a scale
Standard Deviation 2.4
|
17.3 score on a scale
Standard Deviation 2.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
Adverse Events
Arm I (Platinum-based Chemotherapy)
Serious events: 18 serious events
Other events: 169 other events
Deaths: 72 deaths
Arm II (Olaparib)
Serious events: 22 serious events
Other events: 184 other events
Deaths: 95 deaths
Arm III (Olaparib, Cediranib Maleate)
Serious events: 29 serious events
Other events: 184 other events
Deaths: 84 deaths
Japanese Cohort
Serious events: 1 serious events
Other events: 13 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm I (Platinum-based Chemotherapy)
n=187 participants at risk
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm II (Olaparib)
n=189 participants at risk
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
n=189 participants at risk
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
n=13 participants at risk
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Asystole
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Eye Disorders - Other
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colonic Obstruction
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Constipation
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Nausea
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Edema Limbs
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Fatigue
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Death Nos
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Fever
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Infusion Related Reaction
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Infections And Infestations - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Skin Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Sepsis
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Lung Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Enterocolitis Infectious
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Appendicitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Platelet Count Decreased
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Electrocardiogram Qt Corrected Interval Prolonged
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Creatinine Increased
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Neutrophil Count Decreased
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - O
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment Related Secondary Malignancy
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Stroke
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Lethargy
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Headache
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Syncope
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Dizziness
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Depression
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Vasculitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Thromboembolic Event
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Peripheral Ischemia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Hypertension
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
6.3%
12/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
Other adverse events
| Measure |
Arm I (Platinum-based Chemotherapy)
n=187 participants at risk
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm II (Olaparib)
n=189 participants at risk
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Olaparib, Cediranib Maleate)
n=189 participants at risk
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Japanese Cohort
n=13 participants at risk
A small Japanese run-in cohort to assess the toxicity profile and the frequency of unexpected toxicities in the Japanese population when the olaparib and cediranib combination is administered
|
|---|---|---|---|---|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Palpitations
|
3.7%
7/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Heart Failure
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Tinnitus
|
4.3%
8/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Hearing Impaired
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Atrial Flutter
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Cardiac Disorders - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Pericardial Effusion
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Sinus Tachycardia
|
3.2%
6/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Middle Ear Inflammation
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders - Other
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Vertigo
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Hemolytic Uremic Syndrome
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Anemia
|
51.3%
96/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
49.7%
94/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
19.6%
37/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.1%
3/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Asystole
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Ear Pain
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Endocrine disorders
Hypothyroidism
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
31.7%
60/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
53.8%
7/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Endocrine disorders
Hyperthyroidism
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.4%
14/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Endocrine disorders
Endocrine Disorders - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Eye Disorders - Other
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Watering Eyes
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Eye Pain
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Glaucoma
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Cataract
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Photophobia
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Conjunctivitis
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Blurred Vision
|
8.6%
16/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.9%
15/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Dry Eye
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Floaters
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Dysphagia
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
14/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.8%
26/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.5%
18/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Duodenal Fistula
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Dry Mouth
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.2%
25/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colonic Ulcer
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colonic Obstruction
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colonic Fistula
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Constipation
|
38.0%
71/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
37.0%
70/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
32.3%
61/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
40/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
27.0%
51/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
79.9%
151/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
84.6%
11/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Vomiting
|
20.9%
39/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
34.4%
65/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
44.4%
84/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
46.2%
6/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Bloating
|
3.7%
7/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
12.2%
23/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.0%
17/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Stomach Pain
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Salivary Duct Inflammation
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Rectal Mucositis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.3%
38/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
31.7%
60/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
41.3%
78/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Mucositis Oral
|
23.0%
43/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
10.6%
20/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
33.9%
64/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
30.8%
4/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
6.3%
12/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Anal Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Ileus
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.4%
2/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Ileal Obstruction
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Oral Pain
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Nausea
|
57.8%
108/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
63.5%
120/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
71.4%
135/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
53.8%
7/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastroparesis
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
6.4%
12/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.3%
10/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.9%
15/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Rectal Pain
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Jejunal Perforation
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Ascites
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.4%
2/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Toothache
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Esophageal Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
General Disorders And Administration Site Conditio
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Pain
|
8.0%
15/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.5%
18/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.2%
25/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Neck Edema
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Malaise
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
53.8%
7/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Localized Edema
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Irritability
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Flu Like Symptoms
|
7.5%
14/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Non-Cardiac Chest Pain
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
6.3%
12/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Edema Limbs
|
8.6%
16/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
16.4%
31/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
12.7%
24/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.4%
2/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Edema Face
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Fatigue
|
55.6%
104/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
66.1%
125/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
78.3%
148/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.4%
2/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Death Nos
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Fever
|
6.4%
12/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.0%
17/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Gait Disturbance
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Chills
|
5.3%
10/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
6.9%
13/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Infusion Related Reaction
|
7.0%
13/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Hepatobiliary disorders
Gallbladder Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Immune system disorders
Anaphylaxis
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Immune system disorders
Allergic Reaction
|
6.4%
12/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Infections And Infestations - Other
|
3.7%
7/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
8.5%
16/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Wound Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Upper Respiratory Infection
|
4.3%
8/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
10.1%
19/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Tooth Infection
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Vulval Infection
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Skin Infection
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Sinusitis
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Sepsis
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Rhinitis Infective
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Otitis Media
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Papulopustular Rash
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Nail Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Lymph Gland Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Lung Infection
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Laryngitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Eye Infection
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Gum Infection
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Vaginal Infection
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Urinary Tract Infection
|
10.2%
19/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.2%
25/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
20.1%
38/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Bronchial Infection
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Enterocolitis Infectious
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Bladder Infection
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Lip Infection
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Appendicitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications - O
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Injury To Carotid Artery
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Burn
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Bruising
|
7.0%
13/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Investigations - Other
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Weight Loss
|
4.8%
9/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
6.9%
13/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
30.7%
58/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
46.2%
6/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Weight Gain
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Serum Amylase Increased
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Platelet Count Decreased
|
35.8%
67/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.1%
21/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
21.2%
40/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
30.8%
4/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Lymphocyte Count Decreased
|
12.8%
24/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
16.9%
32/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.9%
15/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Lipase Increased
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Inr Increased
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Hemoglobin Increased
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Electrocardiogram Qt Corrected Interval Prolonged
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Creatinine Increased
|
6.4%
12/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
21.7%
41/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
17.5%
33/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Cholesterol High
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Neutrophil Count Decreased
|
56.1%
105/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
12.7%
24/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
16.9%
32/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
30.8%
4/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Urine Output Decreased
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Cardiac Troponin I Increased
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Blood Bilirubin Increased
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
White Blood Cell Decreased
|
35.8%
67/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
20.6%
39/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
17.5%
33/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.1%
3/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Aspartate Aminotransferase Increased
|
9.1%
17/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.5%
18/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
38.5%
5/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Alkaline Phosphatase Increased
|
7.5%
14/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.0%
17/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.1%
3/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Alanine Aminotransferase Increased
|
7.5%
14/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.1%
21/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
38.5%
5/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.6%
16/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.8%
26/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
16.4%
31/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.1%
32/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.6%
22/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.8%
24/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.9%
15/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
16.4%
31/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.4%
27/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
8.5%
16/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
17/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
8.5%
16/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.8%
26/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.1%
3/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.8%
22/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
21.2%
40/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.2%
25/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Dehydration
|
6.4%
12/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.9%
15/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
10.6%
20/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Anorexia
|
19.8%
37/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
27.5%
52/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
41.3%
78/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
69.2%
9/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Acidosis
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.6%
18/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
14.3%
27/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.3%
29/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
17/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.1%
21/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
12.2%
23/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Deformity
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Left-Sided
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased Lumbar Spine
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
7.5%
14/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.3%
10/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.2%
25/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.0%
13/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.0%
15/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.6%
22/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
18.0%
34/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
19/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
12.2%
23/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.6%
22/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - O
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.3%
10/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia Secondary To Oncology Chemotherapy
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Nervous System Disorders - Other
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Trigeminal Nerve Disorder
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Tremor
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Transient Ischemic Attacks
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Stroke
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Somnolence
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Seizure
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Presyncope
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
29.9%
56/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.9%
30/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.8%
26/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Paresthesia
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Neuralgia
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Memory Impairment
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Lethargy
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Headache
|
18.2%
34/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
17.5%
33/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
33.3%
63/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
38.5%
5/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Extrapyramidal Disorder
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Encephalopathy
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Dysgeusia
|
4.8%
9/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.2%
25/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.9%
30/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.4%
2/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Sinus Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Syncope
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Dizziness
|
11.8%
22/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
16.4%
31/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
21.2%
40/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Concentration Impairment
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Cognitive Disturbance
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Ataxia
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Amnesia
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Akathisia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Psychiatric Disorders - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Suicidal Ideation
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Personality Change
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Mania
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Libido Decreased
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Insomnia
|
11.2%
21/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
12.2%
23/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.4%
14/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Depression
|
8.6%
16/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
8.5%
16/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.0%
17/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Delirium
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Confusion
|
3.7%
7/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Anxiety
|
4.3%
8/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
6.9%
13/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.0%
17/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Agitation
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Tract Pain
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Urgency
|
5.3%
10/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Incontinence
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Frequency
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.8%
9/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Proteinuria
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.0%
17/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
30.8%
4/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Hematuria
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.7%
7/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Cystitis Noninfective
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.4%
2/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Pain
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Perineal Pain
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Pelvic Pain
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Breast Pain
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.6%
22/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.0%
17/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.1%
2/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Mucositis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.7%
7/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.9%
15/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.1%
4/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.8%
26/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.4%
2/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
34/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.8%
45/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
27.5%
52/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.4%
27/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
18.5%
35/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.3%
44/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
3.7%
7/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
3.7%
7/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
6.9%
13/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.9%
15/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
4.3%
8/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
5.3%
10/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.6%
5/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.8%
11/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
5.9%
11/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
6.3%
12/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
30.8%
4/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
10.2%
19/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.4%
14/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
12.2%
23/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.53%
1/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
1.6%
3/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
4.8%
9/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.1%
2/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.4%
14/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.4%
2/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.2%
19/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.4%
14/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
10.6%
20/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.7%
1/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Vascular Disorders - Other
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Visceral Arterial Ischemia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Vasculitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Thromboembolic Event
|
3.7%
7/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.2%
6/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.4%
14/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Superficial Thrombophlebitis
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Peripheral Ischemia
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Lymphedema
|
0.00%
0/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Hypotension
|
2.7%
5/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
10.1%
19/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Hypertension
|
8.0%
15/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
12.7%
24/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
67.7%
128/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
84.6%
11/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Hot Flashes
|
6.4%
12/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.3%
10/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
4.2%
8/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Flushing
|
2.1%
4/187 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.53%
1/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
1.6%
3/189 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/13 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner, up to 39 months.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60