Trial Outcomes & Findings for Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer (NCT NCT00803062)
NCT ID: NCT00803062
Last Updated: 2019-07-23
Results Overview
The observed length of life from randomization into the study to death or the date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
From entry into the study to death or the date of last contact, assessed up to 5 years
Results posted on
2019-07-23
Participant Flow
The study was activated on 4/6/2009 and closed to accrual on 1/3/2012.
Participant milestones
| Measure |
Arm I (Paclitaxel and Cisplatin)
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
|
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Arm III (Topotecan Hydrochloride and Paclitaxel)
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
|
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
114
|
115
|
111
|
112
|
|
Overall Study
COMPLETED
|
114
|
115
|
111
|
112
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Paclitaxel and Cisplatin)
n=114 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
|
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
n=115 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Arm III (Topotecan Hydrochloride and Paclitaxel)
n=111 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
|
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
n=112 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
20-29 years
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Age, Customized
30-39 years
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
30 participants
n=5 Participants
|
12 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
Age, Customized
40-49 years
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
33 participants
n=5 Participants
|
41 participants
n=4 Participants
|
144 participants
n=21 Participants
|
|
Age, Customized
50-59 years
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
24 participants
n=5 Participants
|
37 participants
n=4 Participants
|
116 participants
n=21 Participants
|
|
Age, Customized
60-69 years
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
17 participants
n=5 Participants
|
12 participants
n=4 Participants
|
56 participants
n=21 Participants
|
|
Age, Customized
70-79 years
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Age, Customized
80-89 years
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
452 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From entry into the study to death or the date of last contact, assessed up to 5 yearsPopulation: All randomized patients.
The observed length of life from randomization into the study to death or the date of last contact.
Outcome measures
| Measure |
Arm I (Paclitaxel and Cisplatin)
n=114 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
|
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
n=115 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Arm III (Topotecan Hydrochloride and Paclitaxel)
n=111 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
|
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
n=112 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
|---|---|---|---|---|
|
Overall Survival
|
14.26 months
Interval 10.83 to 16.82
|
17.51 months
Interval 13.96 to 22.93
|
12.68 months
Interval 10.15 to 15.9
|
16.20 months
Interval 12.71 to 18.96
|
PRIMARY outcome
Timeframe: From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)Population: All randomized patients.
Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
Outcome measures
| Measure |
Arm I (Paclitaxel and Cisplatin)
n=114 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
|
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
n=115 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Arm III (Topotecan Hydrochloride and Paclitaxel)
n=111 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
|
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
n=112 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
|---|---|---|---|---|
|
Progression-free Survival
|
6.67 months
Interval 5.72 to 8.08
|
9.63 months
Interval 7.16 to 12.68
|
5.29 months
Interval 4.27 to 6.8
|
7.36 months
Interval 5.75 to 9.56
|
PRIMARY outcome
Timeframe: Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.Population: All randomized patients.
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I (Paclitaxel and Cisplatin)
n=114 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
|
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
n=115 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Arm III (Topotecan Hydrochloride and Paclitaxel)
n=111 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
|
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
n=112 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
|---|---|---|---|---|
|
Tumor Response
|
44.74 percentage of participants
Interval 35.42 to 54.34
|
49.57 percentage of participants
Interval 40.11 to 59.04
|
27.03 percentage of participants
Interval 19.03 to 36.28
|
47.32 percentage of participants
Interval 37.81 to 56.98
|
PRIMARY outcome
Timeframe: From date of enrollment until 30 days after treatment completionPopulation: Eligible and treated patients
The number of patients on each arm who have Grade 3 AE or higher toxicity.
Outcome measures
| Measure |
Arm I (Paclitaxel and Cisplatin)
n=114 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
|
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
n=115 Participants
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Arm III (Topotecan Hydrochloride and Paclitaxel)
n=111 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
|
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
n=112 Participants
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
|---|---|---|---|---|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Death, Not CTC coded
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Leukopenia
|
34 Participants
|
48 Participants
|
48 Participants
|
66 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Thrombocytopenia
|
6 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Neutropenia
|
48 Participants
|
61 Participants
|
61 Participants
|
79 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Anemia
|
33 Participants
|
29 Participants
|
23 Participants
|
30 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Other hematologic
|
3 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Allergy/Immunology
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Auditory/Ear
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Cardiac
|
2 Participants
|
16 Participants
|
4 Participants
|
14 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Coagulation
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Constitutional
|
12 Participants
|
16 Participants
|
13 Participants
|
16 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Dermatologic
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Endocrine
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Gastrointestinal
|
22 Participants
|
29 Participants
|
11 Participants
|
22 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Genitourinary/Renal
|
10 Participants
|
8 Participants
|
7 Participants
|
14 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Hemorrhage
|
4 Participants
|
7 Participants
|
5 Participants
|
9 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Hepatobiliary
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Infection
|
17 Participants
|
18 Participants
|
19 Participants
|
30 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Lymphatics
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Metabolic
|
18 Participants
|
23 Participants
|
11 Participants
|
17 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Musculoskeletal
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Neuropathy
|
9 Participants
|
12 Participants
|
2 Participants
|
3 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Other Neurological
|
8 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Pain
|
21 Participants
|
30 Participants
|
22 Participants
|
27 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Pulmonary
|
3 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
|
To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
Vascular
|
8 Participants
|
17 Participants
|
6 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAssessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 9 months after course 1Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAssociations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAssociations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAssociations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAssociations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAn estimate of the prevalence of active smoking will be calculated. Will be assessed for associations with progression and/or death.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Paclitaxel and Cisplatin)
Serious events: 42 serious events
Other events: 112 other events
Deaths: 0 deaths
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
Serious events: 53 serious events
Other events: 111 other events
Deaths: 0 deaths
Arm III (Topotecan Hydrochloride and Paclitaxel)
Serious events: 37 serious events
Other events: 107 other events
Deaths: 0 deaths
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
Serious events: 61 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Paclitaxel and Cisplatin)
n=112 participants at risk
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
|
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
n=111 participants at risk
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Arm III (Topotecan Hydrochloride and Paclitaxel)
n=107 participants at risk
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
|
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
n=109 participants at risk
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
|---|---|---|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Neutrophils
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Vasovagal Episode
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Hypotension
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Inr
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Dic
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Fever
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Fatigue
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Death No Ctcae Term - Sudden Death
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Perforation, Gi - Colon
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Fistula, Gi - Small Bowel Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Ulcer,gi - Rectum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Perforation, Gi - Rectum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Dental: Teeth
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Leak, Gi - Rectum
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Obstruction, Gi - Gallbladder
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Constipation
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Perforation, Gi - Ileum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Larynx
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gi - Esophagus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Ureter
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Febrile Neutropenia
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.7%
5/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Blood
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Infection - Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Abdomen Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Pelvis Nos
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Kidney
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Bladder (Urinary)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Peritoneal Cavity
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Nerve-Peripheral
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Catheter-Related
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Left-Sided
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Syncope
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Involuntary Movement
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Mental Status
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Mood Alteration - Depression
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Seizure
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Cognitive Disturbance
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain - Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Pelvis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Chest /Thorax Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Pleura
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Neck
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Extremity-Limb
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Back
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Bone
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Rectum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Abdominal Pain Nos
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.5%
6/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Tumor
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Ards
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Stricture, Anastomotic, Gu - Ureter
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Fistula, Gu - Genital Tract-Female
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Fistula, Gu - Bladder
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Renal Failure
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.2%
8/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Death No Ctcae Term - Multi-Organ Failure
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
Other adverse events
| Measure |
Arm I (Paclitaxel and Cisplatin)
n=112 participants at risk
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
|
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
n=111 participants at risk
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
Arm III (Topotecan Hydrochloride and Paclitaxel)
n=107 participants at risk
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
|
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
n=109 participants at risk
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
|
|---|---|---|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
17.0%
19/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
18.0%
20/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.7%
5/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Immune system disorders
Rhinitis
|
5.4%
6/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.9%
11/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.7%
5/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.2%
10/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Ear and labyrinth disorders
Tinnitus
|
15.2%
17/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Ear and labyrinth disorders
Hearing (Monitoring Program)
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Neutrophils
|
70.5%
79/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
81.1%
90/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
70.1%
75/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
85.3%
93/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Platelets
|
34.8%
39/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
49.5%
55/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
42.1%
45/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
56.0%
61/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Leukocytes
|
78.6%
88/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
85.6%
95/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
83.2%
89/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
90.8%
99/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.8%
12/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.5%
8/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
11.9%
13/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
95.5%
107/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
91.0%
101/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
97.2%
104/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
92.7%
101/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Palpitations
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Ventricular Arrhythmia - Tachycardia
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Vasovagal Episode
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Hypertension
|
8.9%
10/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
32.4%
36/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
24.8%
27/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Left Venticular Diastolic Dysfunction
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Cardiac General - Other
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Pericardial Effusion
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Cardiac disorders
Hypotension
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Inr
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Coagulopathy - Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Ptt
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.4%
6/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Constitutional Symptoms - Other
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Sweating
|
8.0%
9/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.7%
5/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Weight Gain
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.3%
9/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Patient Odor
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Fever
|
14.3%
16/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
15.3%
17/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
12.1%
13/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
14.7%
16/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Weight Loss
|
8.0%
9/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
23.4%
26/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
17.4%
19/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Rigors/Chills
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Fatigue
|
83.0%
93/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
82.0%
91/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
71.0%
76/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
75.2%
82/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Insomnia
|
16.1%
18/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
13.5%
15/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
14.0%
15/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
25.7%
28/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.5%
6/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
61.6%
69/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
58.6%
65/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
64.5%
69/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
65.1%
71/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
14/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
11.7%
13/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
15.0%
16/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
16.5%
18/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
11/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.4%
6/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.7%
5/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
4.5%
5/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
4.5%
5/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Endocrine disorders
Hot Flashes
|
12.5%
14/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.8%
12/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.3%
11/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
11.9%
13/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Endocrine disorders
Diabetes
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Endocrine disorders
Endocrine - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Obstruction, Gi - Ileum
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Ulcer,gi - Anus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Salivary Gland Changes
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Ulcer,gi - Esophagus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Dental: Periodontal
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Fistula, Gi - Small Bowel Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Esophagitis
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Ulcer,gi - Rectum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Heartburn
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
16.2%
18/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.5%
8/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Esophagus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Dental: Teeth
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Pharynx
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Distention
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Taste Alteration
|
8.9%
10/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.9%
11/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.4%
9/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
11.9%
13/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Incontinence, Anal
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.4%
6/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.2%
10/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
5.4%
6/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.3%
8/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Colitis
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Rectum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Obstruction, Gi - Jejunum
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Dentures
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.5%
8/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.2%
10/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Vomiting
|
33.0%
37/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
42.3%
47/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
28.0%
30/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
25.7%
28/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Anorexia
|
26.8%
30/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
37.8%
42/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
25.2%
27/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
30.3%
33/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Dehydration
|
5.4%
6/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.8%
12/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Constipation
|
55.4%
62/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
48.6%
54/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
45.8%
49/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
47.7%
52/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Nausea
|
68.8%
77/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
67.6%
75/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
52.3%
56/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
57.8%
63/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Gastrointestinal disorders
Diarrhea
|
33.9%
38/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
41.4%
46/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
36.4%
39/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
32.1%
35/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
14.3%
16/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
12.6%
14/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.3%
10/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.2%
10/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Urethra
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Lung
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.2%
8/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.2%
10/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Respiratory Tract Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gi - Varices (Rectal)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
13.5%
15/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
20.2%
22/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hematoma
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gi - Anus
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Ureter
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.4%
7/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gu - Kidney
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Gi - Colon
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage, Cns
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Dental-Tooth
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: External Ear
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lip/Perioral
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Joint
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Febrile Neutropenia
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Nerve-Peripheral
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Sinus
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Colon
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
15.3%
17/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.3%
11/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
13.8%
15/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Infection - Other
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.4%
6/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.5%
6/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Vagina
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Mucosa
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Bronchus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Eye Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.4%
6/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.5%
7/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.3%
8/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Bladder (Urinary)
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Wound
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf Unknown Anc: Dental-Tooth
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Vulva
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Pelvis Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Sinus
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Pharynx
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Bronchus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Ureter
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lymphatic
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Catheter-Related
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
23.2%
26/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
13.5%
15/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
21.5%
23/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
17.4%
19/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Blood and lymphatic system disorders
Dermal Change
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Ast
|
5.4%
6/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
15.3%
17/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.4%
9/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.4%
7/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Gfr
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
4.5%
5/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Proteinuria
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
14.4%
16/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.4%
7/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Creatinine
|
14.3%
16/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
21.6%
24/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.1%
11/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.6%
13/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
17.1%
19/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.3%
11/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
14.7%
16/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Ggt
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Alt
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
13.5%
15/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.7%
5/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
13.4%
15/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
18.9%
21/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.3%
11/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.1%
11/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Bilirubin
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.2%
8/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.8%
11/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
21.6%
24/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.3%
10/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
15.6%
17/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.4%
6/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Amylase
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.2%
17/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
18.9%
21/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.5%
7/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.1%
11/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
8/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.1%
9/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.4%
24/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
24.3%
27/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
17.8%
19/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
26.6%
29/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.1%
18/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
21.6%
24/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
11.2%
12/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
14.7%
16/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.5%
5/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.9%
29/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
36.0%
40/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
11.9%
13/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Extremity-Upper (Function)
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Gait/Walking
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
12.5%
14/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.8%
12/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.5%
7/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
13.8%
15/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Syncope
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Involuntary Movement
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Psychosis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Neurology - Other
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Encephalopathy
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Mood Alteration - Depression
|
17.0%
19/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
14.4%
16/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
13.1%
14/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
11.9%
13/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
12.5%
14/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
18.0%
20/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.4%
9/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
14.7%
16/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Neuropathy-Motor
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Eye disorders
Ocular/Visual - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Mood Alteration - Agitation
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Tremor
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Speech Impairment
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Seizure
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Personality
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Irritability
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Somnolence
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Cognitive Disturbance
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Ataxia
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Confusion
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Memory Impairment
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Dizziness
|
11.6%
13/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.1%
9/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.3%
10/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.1%
11/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Neuropathy,cranial - Cn Viii Hearing/Balance
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Neuropathy,cranial - Cn Ii Vision
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Neuropathy,cranial - Cn I Smell
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Nervous system disorders
Neuropathy-Sensory
|
67.9%
76/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
57.7%
64/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
58.9%
63/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
65.1%
71/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Eye disorders
Retinal Detachment
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Eye disorders
Watery Eye
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Eye disorders
Dry Eye
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Eye disorders
Ocular Surface Disease
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Eye disorders
Flashing Lights/Floaters
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Eye disorders
Diplopia
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Eye disorders
Blurred Vision
|
8.9%
10/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.2%
10/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Rectum
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.4%
6/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.3%
8/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain - Other
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.8%
12/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.3%
11/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.5%
6/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Urethra
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Perineum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Pelvis
|
7.1%
8/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
13.5%
15/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.3%
11/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
11.9%
13/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Breast
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Vagina
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Chest /Thorax Nos
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.6%
6/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Chest Wall
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.6%
5/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.5%
6/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Pleura
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Head/Headache
|
10.7%
12/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
23.4%
26/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
15.9%
17/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
19.3%
21/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Neck
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Extremity-Limb
|
23.2%
26/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
16.2%
18/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
16.8%
18/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
16.5%
18/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Buttock
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Back
|
22.3%
25/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
20.7%
23/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
15.0%
16/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
20.2%
22/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Joint
|
15.2%
17/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
21.6%
24/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
21.5%
23/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
22.0%
24/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Bone
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.8%
12/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
14.0%
15/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.3%
9/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Kidney
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Bladder
|
4.5%
5/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Pain Nos
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.2%
8/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Stomach
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Peritoneum
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Oral Cavity
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Abdominal Pain Nos
|
36.6%
41/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
34.2%
38/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
28.0%
30/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
30.3%
33/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Scalp
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Oral - Gums
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Skin
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Middle Ear
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: External Ear
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Cardiac/ Heart
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Tumor
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Muscle
|
18.8%
21/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
15.3%
17/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
19.6%
21/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
22.9%
25/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Neuralgia
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Pain: Sinus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Airway Obstruction - Bronchus
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
3.6%
4/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.2%
10/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.2%
8/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.2%
10/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
18/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.8%
12/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
22.4%
24/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
19.3%
21/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.9%
29/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
23.4%
26/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
20.6%
22/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
21.1%
23/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.4%
6/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.7%
5/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Leak, Gu - Vagina
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Leak, Gu - Urethra
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.7%
3/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Urinary Color Change
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Urinary Retention
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Urinary Electrolyte Wasting
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.7%
4/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
8.0%
9/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.3%
7/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.4%
9/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.3%
8/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
2.7%
3/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Fistula, Gu - Bladder
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Renal Failure
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Renal and urinary disorders
Urinary Frequency
|
8.9%
10/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.9%
11/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
6.5%
7/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
7.3%
8/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Reproductive system and breast disorders
Libido
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Reproductive system and breast disorders
Irregular Menses
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.8%
2/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function: Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Reproductive system and breast disorders
Vaginitis
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Reproductive system and breast disorders
Vaginal Stenosis
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
6.2%
7/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
4.5%
5/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
9.3%
10/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
8.3%
9/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Syndromes - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
1.9%
2/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Cytokine Release Syndrome
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
General disorders
Flu-Like Syndrome
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
3.6%
4/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.93%
1/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.92%
1/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Vascular - Other
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Vein Injury - Other Nos
|
0.00%
0/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.89%
1/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.90%
1/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
0.00%
0/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.8%
2/112 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
10.8%
12/111 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
2.8%
3/107 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
5.5%
6/109 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Center - Buffalo
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60