Trial Outcomes & Findings for Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer (NCT NCT00942357)
NCT ID: NCT00942357
Last Updated: 2021-10-19
Results Overview
Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. 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, or a measurable increase in a non-target lesion or the appearance of new lesions.
Recruitment status
UNKNOWN
Study phase
PHASE3
Target enrollment
813 participants
Primary outcome timeframe
Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.
Results posted on
2021-10-19
Participant Flow
GOG 0258 accrued 813 patients between June 29, 2009 and July 28, 2014.
Participant milestones
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
407
|
406
|
|
Overall Study
COMPLETED
|
370
|
366
|
|
Overall Study
NOT COMPLETED
|
37
|
40
|
Reasons for withdrawal
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
Ineligible
|
37
|
40
|
Baseline Characteristics
Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
n=370 Participants
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
n=366 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Total
n=736 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
132 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
133 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
55 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
370 Participants
n=5 Participants
|
366 Participants
n=7 Participants
|
736 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
338 Participants
n=5 Participants
|
324 Participants
n=7 Participants
|
662 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
291 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
570 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Endometrial Cancer Grades
Endometrioid Grade 1
|
87 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Endometrial Cancer Grades
Endometrioid Grade 2
|
103 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Endometrial Cancer Grades
Endometrioid Grade 3
|
66 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Endometrial Cancer Grades
Serous
|
66 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Endometrial Cancer Grades
Clear Cell
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Endometrial Cancer Grades
Other
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.Population: Number of recurrence, progression or death events in eligible and enrolled patients
Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. 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, or a measurable increase in a non-target lesion or the appearance of new lesions.
Outcome measures
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
n=370 Participants
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
n=366 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Participants With Recurrence, Progression or Death
|
132 participants
|
139 participants
|
SECONDARY outcome
Timeframe: Assessed throughout the treatment period and for 21-30 days after discontinuation of treatmentPopulation: Eligible and treated participants
The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.
Outcome measures
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
n=346 Participants
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
n=361 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0
Grade 1
|
5 Participants
|
15 Participants
|
|
Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0
Grade 2
|
139 Participants
|
118 Participants
|
|
Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0
Grade 3
|
154 Participants
|
119 Participants
|
|
Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0
Grade 4
|
48 Participants
|
105 Participants
|
|
Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0
Grade 5
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed every 6 months for 3 yearsPopulation: All eligible and treated patients
The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.
Outcome measures
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
n=346 Participants
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
n=361 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
Grade 1
|
85 Participants
|
96 Participants
|
|
Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
Grade 2
|
71 Participants
|
79 Participants
|
|
Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
Grade 3
|
45 Participants
|
33 Participants
|
|
Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
Grade 4
|
14 Participants
|
7 Participants
|
|
Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
Grade 5
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From entry into the study to death or the date of last contact, assessed up to 8 yearsIndependence between the two endpoints, RFS and survival, and randomized treatment will be assessed with a stratified logrank test for an intent-to-treat analysis of eligible patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatmentPopulation: Patients who provided baseline and \>= 1 follow-up assessment(s)
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less peripheral neuropathy symptoms.
Outcome measures
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
n=332 Participants
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
n=349 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Patient-reported Peripheral Neuropathy Symptoms
Baseline
|
14.9 unit on a scale
Standard Error 0.1
|
15.0 unit on a scale
Standard Error 0.1
|
|
Patient-reported Peripheral Neuropathy Symptoms
6 weeks
|
14.4 unit on a scale
Standard Error 0.4
|
12.4 unit on a scale
Standard Error 0.4
|
|
Patient-reported Peripheral Neuropathy Symptoms
18 weeks
|
10.4 unit on a scale
Standard Error 0.4
|
9.9 unit on a scale
Standard Error 0.5
|
|
Patient-reported Peripheral Neuropathy Symptoms
70 weeks
|
11.8 unit on a scale
Standard Error 0.4
|
11.6 unit on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatmentPopulation: Patients who provided baseline and \>= 1 follow-up assessments
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL.
Outcome measures
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
n=332 Participants
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
n=349 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Patient-reported Quality of Life (QOL)
Baseline
|
98.4 units on a scale
Standard Error 0.8
|
97.6 units on a scale
Standard Error 0.8
|
|
Patient-reported Quality of Life (QOL)
6 weeks
|
89.5 units on a scale
Standard Error 2.1
|
90.9 units on a scale
Standard Error 2.0
|
|
Patient-reported Quality of Life (QOL)
18 weeks
|
87.8 units on a scale
Standard Error 2.1
|
93.0 units on a scale
Standard Error 2.0
|
|
Patient-reported Quality of Life (QOL)
70 weeks
|
96.0 units on a scale
Standard Error 2.2
|
99.4 units on a scale
Standard Error 2.1
|
Adverse Events
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
Serious events: 78 serious events
Other events: 346 other events
Deaths: 0 deaths
Arm II (Paclitaxel and Carboplatin)
Serious events: 61 serious events
Other events: 360 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
n=346 participants at risk
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
n=361 participants at risk
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Neutrophils
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
7.5%
27/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.2%
4/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Vasovagal Episode
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Hypotension
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Fever
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Fatigue
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Death No Ctcae Term - Death Nos
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Enteritis
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Obstruction, Gi - Ileum
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Obstruction, Gi - Rectum
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Anorexia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Dehydration
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Nausea
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
9/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Febrile Neutropenia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Blood
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Infection - Other
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Pelvis Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Lymphatic
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Kidney
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Wound
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Pelvis Nos
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Alt
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Syncope
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Psychosis
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Neurology - Other
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Seizure
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Uveitis
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Head/Headache
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Back
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Abdominal Pain Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Cardiac/ Heart
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Neuralgia
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Renal Failure
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.7%
6/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
Other adverse events
| Measure |
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)
n=346 participants at risk
Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Cisplatin: Given IV
Internal Radiation Therapy: Undergo brachytherapy
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
Radiation Therapy: Undergo radiation therapy
|
Arm II (Paclitaxel and Carboplatin)
n=361 participants at risk
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Immune system disorders
Allergy/Immunology - Other
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
4.3%
15/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
7.8%
28/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Immune system disorders
Rhinitis
|
2.0%
7/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
4.2%
15/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Immune system disorders
Autoimmune Reaction
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
1.2%
4/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.2%
18/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.6%
13/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Neutrophils
|
50.9%
176/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
68.1%
246/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Platelets
|
62.7%
217/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
54.0%
195/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
3.5%
12/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.3%
19/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Bone Marrow Cellularity
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Leukocytes
|
82.9%
287/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
72.6%
262/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
15.3%
53/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.8%
21/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
89.3%
309/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
80.9%
292/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Palpitations
|
4.0%
14/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.9%
7/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Ventricular Arrhythmia - Tachycardia
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Flutter
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
3.2%
11/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.2%
8/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Tachycardia
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Hypertension
|
6.9%
24/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
12.7%
46/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Valvular Heart Disease
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Cardiac General - Other
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Pericarditis
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Cardiac disorders
Hypotension
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.8%
10/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Inr
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.7%
6/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Coagulopathy - Other
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Ptt
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Constitutional Symptoms - Other
|
3.2%
11/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.6%
13/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Sweating
|
2.9%
10/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.2%
8/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Weight Gain
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
4.2%
15/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Fever
|
8.1%
28/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.9%
14/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Weight Loss
|
11.8%
41/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.3%
12/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Obesity
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Rigors/Chills
|
4.6%
16/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
4.2%
15/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Fatigue
|
85.0%
294/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
75.1%
271/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Insomnia
|
16.2%
56/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
17.5%
63/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
2.6%
9/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.9%
14/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
60.1%
208/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
71.5%
258/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis - Chemoradiation
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.3%
8/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.9%
48/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
12.2%
44/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.6%
9/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.6%
13/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis - Radiation
|
4.9%
17/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
15/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.3%
19/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.2%
11/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.8%
10/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
5.2%
18/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.9%
14/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Endocrine disorders
Hot Flashes
|
11.0%
38/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
10.5%
38/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Endocrine disorders
Diabetes
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Endocrine disorders
Endocrine - Other
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Proctitis
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
8/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Ulcer,gi - Stoma
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.8%
13/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Heartburn
|
7.8%
27/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
6.1%
22/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Dental: Teeth
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Pharynx
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Ascites
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Leak, Gi - Rectum
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.9%
7/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Distention
|
4.3%
15/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.9%
7/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Taste Alteration
|
9.8%
34/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
10.5%
38/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Incontinence, Anal
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Fistula, Gi - Abdomen Nos
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Dry Mouth
|
2.9%
10/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.5%
9/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Rectum
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
4.0%
14/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
4.7%
17/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Rectum
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Anus
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Dentures
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
4.0%
14/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.0%
18/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Vomiting
|
30.1%
104/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
21.1%
76/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Anorexia
|
35.0%
121/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
23.3%
84/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Dehydration
|
8.4%
29/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.0%
11/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Constipation
|
40.2%
139/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
47.9%
173/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Nausea
|
67.9%
235/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
50.7%
183/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
3.8%
13/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Diarrhea
|
73.1%
253/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
26.3%
95/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Pharynx
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.7%
6/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
2.0%
7/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.7%
6/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hematoma
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Gi - Lower Gi Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Gi - Colon
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage, Cns
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Petechiae
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Wound
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Neck Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Febrile Neutropenia
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Rectum
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Colon
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
5.5%
19/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.9%
14/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails)
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Blood
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Infection - Other
|
4.6%
16/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.5%
9/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Vulva
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Vagina
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Mucosa
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Bronchus
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Soft Tissue Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
3.8%
13/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.3%
12/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Urethra
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Kidney
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Bladder (Urinary)
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Catheter-Related
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Abdomen Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Sinus
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Urinary Retention
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Joint
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lymphatic
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urethra
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Lymphocele
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
16.2%
56/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
14.1%
51/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Ast
|
6.6%
23/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
9.4%
34/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Gfr
|
1.2%
4/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
2.3%
8/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.5%
9/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Proteinuria
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Creatinine
|
11.3%
39/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
6.6%
24/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.4%
29/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
9.1%
33/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Ggt
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Alt
|
8.1%
28/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
9.1%
33/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
11.6%
40/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
9.7%
35/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Bilirubin
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.3%
39/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
8.6%
31/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.0%
7/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.1%
35/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.5%
20/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
14/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.9%
7/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.5%
78/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
20.2%
73/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.5%
50/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
12.2%
44/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.0%
11/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.2%
70/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
14.7%
53/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
2.3%
8/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.8%
10/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spine Rom
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Gait/Walking
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.2%
8/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
10.4%
36/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.3%
19/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Right-Sided
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
5.2%
18/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.0%
11/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Syncope
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Involuntary Movement
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Psychosis
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Neurology - Other
|
2.3%
8/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.5%
9/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Mental Status
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Mood Alteration - Euphoria
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Mood Alteration - Depression
|
10.1%
35/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
10.2%
37/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
10.1%
35/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
11.4%
41/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Mood Alteration - Agitation
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.9%
7/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Tremor
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Speech Impairment
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Seizure
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Personality
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Irritability
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Cognitive Disturbance
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.7%
6/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Ataxia
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Confusion
|
1.2%
4/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Memory Impairment
|
2.9%
10/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.3%
12/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Dizziness
|
11.6%
40/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
15.8%
57/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Neuropathy,cranial - Cn Viii Hearing/Balance
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Neuropathy,cranial - Cn I Smell
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Neuropathy-Sensory
|
66.5%
230/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
70.1%
253/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Nervous system disorders
Neuropathy-Motor
|
3.2%
11/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.8%
21/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Retinopathy
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Ocular/Visual - Other
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Vitreous Hemorrhage
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Watery Eye
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Dry Eye
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Ocular Surface Disease
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Cataract
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Photophobia
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Flashing Lights/Floaters
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.7%
6/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Diplopia
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Eye disorders
Blurred Vision
|
5.5%
19/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
6.9%
25/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain - Other
|
6.9%
24/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.0%
18/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Urethra
|
4.3%
15/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Perineum
|
1.2%
4/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Pelvis
|
2.3%
8/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.0%
11/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Breast
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Vagina
|
2.3%
8/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Chest /Thorax Nos
|
2.9%
10/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.9%
7/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Chest Wall
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.7%
6/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Larynx
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Eye
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Head/Headache
|
12.1%
42/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
15.5%
56/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Neck
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Intestine
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Extremity-Limb
|
13.9%
48/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
17.5%
63/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Buttock
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Back
|
7.2%
25/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
9.4%
34/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Joint
|
22.0%
76/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
28.3%
102/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Bone
|
19.7%
68/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
11.1%
40/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Gallbladder
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Kidney
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Bladder
|
4.6%
16/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Pain Nos
|
2.6%
9/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.2%
8/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Stomach
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Rectum
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Peritoneum
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Oral Cavity
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Esophagus
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Abdominal Pain Nos
|
22.8%
79/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
14.7%
53/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Scalp
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Oral - Gums
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Skin
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Middle Ear
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Cardiac/ Heart
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Muscle
|
19.4%
67/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
22.7%
82/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Anus
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Neuralgia
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Pain: Sinus
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
2.0%
7/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.83%
3/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.9%
7/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Edema, Larynx
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
36/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
12.5%
45/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.0%
76/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
18.0%
65/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
5.5%
19/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.4%
5/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Leak, Gu - Vagina
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Cystitis
|
5.5%
19/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Urinary Color Change
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Obstruction, Gu - Stoma
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Obstruction, Gu - Bladder
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
10.1%
35/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
3.9%
14/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Renal Failure
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Renal and urinary disorders
Urinary Frequency
|
17.6%
61/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
5.8%
21/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Mal: Poss. Related To Cancer Rx
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Reproductive system and breast disorders
Breast
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
1.2%
4/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.55%
2/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function: Other
|
0.87%
3/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.1%
4/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Reproductive system and breast disorders
Vaginitis
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Reproductive system and breast disorders
Vaginal Stenosis
|
1.2%
4/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Reproductive system and breast disorders
Vaginal Mucositis
|
1.4%
5/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
3.5%
12/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
1.9%
7/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Reproductive system and breast disorders
Orgasmic Function
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Surgical and medical procedures
Intra-Op Injury: Urinary Tract Nos
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Surgical and medical procedures
Intra-Op Injury: Other
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Syndromes - Other
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Cytokine Release Syndrome
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
General disorders
Flu-Like Syndrome
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.2%
8/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Vascular - Other
|
0.58%
2/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Portal Flow
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.00%
0/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Artery Injury - Visceral
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.00%
0/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.7%
6/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
2.5%
9/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
|
Vascular disorders
Phlebitis
|
0.29%
1/346 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
0.28%
1/361 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.
|
Additional Information
Linda Gedeon on behalf of Virginia Filiaci, PhD. and Helen Huang, MS.
NRG Oncology
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60