Trial Outcomes & Findings for Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers (NCT NCT02466971)
NCT ID: NCT02466971
Last Updated: 2026-04-13
Results Overview
Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
450 participants
Primary outcome timeframe
At 3 years from randomization.
Results posted on
2026-04-13
Participant Flow
NRG-GY006 opened to accrual on January 15, 2016, and closed to accrual on September 22, 2022.
Participant milestones
| Measure |
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
External Beam Radiation Therapy: Undergo EBRT
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
|
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
Triapine: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
225
|
225
|
|
Overall Study
COMPLETED
|
207
|
202
|
|
Overall Study
NOT COMPLETED
|
18
|
23
|
Reasons for withdrawal
| Measure |
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
External Beam Radiation Therapy: Undergo EBRT
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
|
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
Triapine: Given IV
|
|---|---|---|
|
Overall Study
eligible and never treated
|
14
|
20
|
|
Overall Study
too early for evaluation of treatment and toxicity
|
3
|
2
|
|
Overall Study
ineligible and treated
|
1
|
0
|
|
Overall Study
ineligible and never treated
|
0
|
1
|
Baseline Characteristics
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
Baseline characteristics by cohort
| Measure |
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
n=224 Participants
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
External Beam Radiation Therapy: Undergo EBRT
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
|
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
n=224 Participants
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
Triapine: Given IV
|
Total
n=448 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=193 Participants
|
47 years
n=193 Participants
|
47 years
n=386 Participants
|
|
Age, Customized
20-29 years
|
7 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
15 Participants
n=386 Participants
|
|
Age, Customized
30-39 years
|
58 Participants
n=193 Participants
|
50 Participants
n=193 Participants
|
108 Participants
n=386 Participants
|
|
Age, Customized
40-49 years
|
64 Participants
n=193 Participants
|
73 Participants
n=193 Participants
|
137 Participants
n=386 Participants
|
|
Age, Customized
50-59 years
|
57 Participants
n=193 Participants
|
49 Participants
n=193 Participants
|
106 Participants
n=386 Participants
|
|
Age, Customized
60-69 years
|
27 Participants
n=193 Participants
|
27 Participants
n=193 Participants
|
54 Participants
n=386 Participants
|
|
Age, Customized
70-79 years
|
9 Participants
n=193 Participants
|
13 Participants
n=193 Participants
|
22 Participants
n=386 Participants
|
|
Age, Customized
>= 80 years
|
2 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
|
Sex: Female, Male
Female
|
224 Participants
n=193 Participants
|
224 Participants
n=193 Participants
|
448 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=193 Participants
|
57 Participants
n=193 Participants
|
101 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
169 Participants
n=193 Participants
|
164 Participants
n=193 Participants
|
333 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
10 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
16 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=193 Participants
|
36 Participants
n=193 Participants
|
68 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=193 Participants
|
160 Participants
n=193 Participants
|
325 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=193 Participants
|
15 Participants
n=193 Participants
|
27 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: At 3 years from randomization.Population: Eligible participants
Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
Outcome measures
| Measure |
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
n=224 Participants
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
External Beam Radiation Therapy: Undergo EBRT
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
|
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
n=224 Participants
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
Triapine: Given IV
|
|---|---|---|
|
Overall Survival (OS) Rate at 3 Years
|
78.1 percentage of participants
Interval 70.0 to 84.0
|
79.6 percentage of participants
Interval 72.0 to 85.0
|
SECONDARY outcome
Timeframe: At 3 years from study randomization.Population: Eligible participants
Estimate for probability of progression free at 3 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the date of first documented disease recurrence/progression, death from any cause or date of last contact, whichever occurs first. Recurrence is defined as clinical, radiological or histological evidence of recurrent disease post study treatment. Disease progression will be determined from the physical examinations, which were conducted during treatment (day 9, 16, 23, 30 and 37) and follow-up (1 and 3 months after completing protocol therapy, every 3 months for years 1 and 2, and every 6 months for years 3, 4 and 5), and the PET/CT scan conducted 3 months after the end of treatment. Please note that progression defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) is not required by the protocol.
Outcome measures
| Measure |
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
n=224 Participants
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
External Beam Radiation Therapy: Undergo EBRT
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
|
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
n=224 Participants
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
Triapine: Given IV
|
|---|---|---|
|
Progression-free Survival (PFS) Rate at 3 Years
|
69.5 percentage of participants
Interval 62.0 to 76.0
|
71.4 percentage of participants
Interval 64.0 to 78.0
|
SECONDARY outcome
Timeframe: During treatment period and up to 30 days after stopping the study treatment with a median treatment time as 53 days ranging from 1 to 189 days.Population: Participants who received any study treatment
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Outcome measures
| Measure |
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
n=208 Participants
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
External Beam Radiation Therapy: Undergo EBRT
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
|
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
n=202 Participants
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
Triapine: Given IV
|
|---|---|---|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Anemia
|
23 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Other blood and lymphatic system disorders
|
5 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
White blood cell count decreased
|
19 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Platelet count decreased
|
5 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Neutrophil count decreased
|
13 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Other investigations
|
39 Participants
|
41 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Cardiac disorders
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Eye disorders
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Gastrointestinal disorders
|
22 Participants
|
22 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
General disorders
|
7 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Hepatobiliary disorders
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Infections and infestations
|
17 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Metabolism and nutrition disorders
|
29 Participants
|
22 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Musculoskeletal and connective tissue disorders
|
2 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Neoplasms benign, malignant and unspecified
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Nervous system disorders
|
5 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Psychiatric disorders
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Renal and urinary disorders
|
3 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Reproductive system and breast disorders
|
8 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Respiratory, thoracic and mediastinal disorders
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Skin and subcutaneous tissue disorders
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Surgical and medical procedures
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
Vascular disorders
|
20 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days after completion of study treatmentNumber of participants with hematologic toxicity during treatment period, where hematologic toxicity is defined as occurrence of any grade 3 or higher adverse events for neutropenia, leukopenia, lymphopenia, anemia, or thrombocytopenia. Adverse events are graded and categorized using CTCAE v4.0.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsNumber of participants with a maximum grade of 3 or higher that occurred during follow-up period. Adverse events are graded and categorized using CTCAE v4.0.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 24 hours after triapine infusionPeripheral blood methemoglobin collected at baseline and 1, 3, 5 and 24 hours after Triapine infusion on Day 1 in Arm II.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 months after completion of treatmentThe assessment of metabolic complete response is based on the ratio of post 3-month therapy PET/CT maximum standardized update value (SUV) to pre-therapy PET/CT maximum SUV. The metabolic complete response is classified as complete response for a ratio of 0.33 or less, or partial response for a ratio between 0.34 and 0.75, or stable response for a ratio greater that 0.75 but less than 1.25, or progressive response for a ratio greater than 1.25.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 60 days.Number of Participants with KBP IG-IMRT
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
Serious events: 45 serious events
Other events: 198 other events
Deaths: 35 deaths
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
Serious events: 45 serious events
Other events: 194 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
n=208 participants at risk
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
External Beam Radiation Therapy: Undergo EBRT
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
|
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
n=202 participants at risk
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
Triapine: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
6/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Colitis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Vomiting
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Duodenal Hemorrhage
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Nausea
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
General Disorders And Administration Site Conditio
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Non-Cardiac Chest Pain
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Fatigue
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Fever
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Infections And Infestations - Other
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Wound Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Sepsis
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Kidney Infection
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Appendicitis
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Injury, poisoning and procedural complications
Uterine Perforation
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Lymphocyte Count Decreased
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
White Blood Cell Decreased
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Alanine Aminotransferase Increased
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Stroke
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Syncope
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Dizziness
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Thromboembolic Event
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Hypertension
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
Other adverse events
| Measure |
Arm I (Cisplatin, IMRT or RT, Brachytherapy)
n=208 participants at risk
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
External Beam Radiation Therapy: Undergo EBRT
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
|
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
n=202 participants at risk
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
Brachytherapy: Undergo brachytherapy
Cisplatin: Given IV
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Radiation Therapy: Undergo conventional RT
Triapine: Given IV
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
21.6%
45/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
10.4%
21/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Ear and labyrinth disorders
Vertigo
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Blood and lymphatic system disorders
Anemia
|
50.5%
105/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
52.0%
105/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Palpitations
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
3.5%
7/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Cardiac Disorders - Other
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Sinus Tachycardia
|
3.8%
8/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
5.9%
12/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders - Other
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Endocrine disorders
Hypothyroidism
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Endocrine disorders
Endocrine Disorders - Other
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Eye Disorders - Other
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Watering Eyes
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Eye Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Glaucoma
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Cataract
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Conjunctivitis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Blurred Vision
|
2.9%
6/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
3.0%
6/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Dry Eye
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Eye disorders
Floaters
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Enterocolitis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Dysphagia
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
14/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
10.9%
22/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Dry Mouth
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Colitis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Constipation
|
30.8%
64/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
36.1%
73/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
144/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
68.8%
139/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Vomiting
|
28.8%
60/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
27.2%
55/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Bloating
|
2.9%
6/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Duodenal Hemorrhage
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Stomach Pain
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.5%
9/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Anal Mucositis
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Rectal Fistula
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.2%
44/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
24.8%
50/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
2.9%
6/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
3.5%
7/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Mucositis Oral
|
4.3%
9/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.5%
9/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
4.3%
9/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Anal Pain
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Ileus
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Nausea
|
67.8%
141/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
62.4%
126/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Pancreatitis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
7.7%
16/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
7.4%
15/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Rectal Pain
|
3.8%
8/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Toothache
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Gastrointestinal disorders
Gastritis
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
General Disorders And Administration Site Conditio
|
3.4%
7/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
6.4%
13/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Pain
|
6.7%
14/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
12.4%
25/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Malaise
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Localized Edema
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Flu Like Symptoms
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Edema Trunk
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Non-Cardiac Chest Pain
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
7.4%
15/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Edema Limbs
|
4.8%
10/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
8.4%
17/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Facial Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Edema Face
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Fatigue
|
58.7%
122/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
59.4%
120/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Fever
|
7.2%
15/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
9.4%
19/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Chills
|
4.3%
9/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
3.5%
7/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
General disorders
Infusion Related Reaction
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Hepatobiliary disorders
Cholecystitis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Immune system disorders
Allergic Reaction
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Infections And Infestations - Other
|
2.9%
6/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
6.4%
13/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Wound Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Upper Respiratory Infection
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Tooth Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Skin Infection
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
3.0%
6/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Sinusitis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Sepsis
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Peripheral Nerve Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Papulopustular Rash
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Lung Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Kidney Infection
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Device Related Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Vaginal Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Urinary Tract Infection
|
19.7%
41/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
17.8%
36/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Lip Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Infections and infestations
Abdominal Infection
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications - O
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Injury, poisoning and procedural complications
Uterine Perforation
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
2.9%
6/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
9.4%
19/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Injury, poisoning and procedural complications
Bruising
|
3.8%
8/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Investigations - Other
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Weight Loss
|
8.7%
18/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.0%
8/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Weight Gain
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Platelet Count Decreased
|
33.2%
69/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
36.6%
74/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Lymphocyte Count Decreased
|
23.1%
48/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
25.2%
51/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Inr Increased
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Ggt Increased
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Creatinine Increased
|
16.8%
35/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
8.4%
17/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Cholesterol High
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Neutrophil Count Decreased
|
17.8%
37/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
13.9%
28/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Cd4 Lymphocytes Decreased
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Blood Bilirubin Increased
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
White Blood Cell Decreased
|
42.3%
88/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
37.1%
75/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.2%
15/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
7.4%
15/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Alkaline Phosphatase Increased
|
6.7%
14/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
6.9%
14/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Alanine Aminotransferase Increased
|
13.9%
29/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
10.9%
22/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
3.4%
7/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Obesity
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.4%
7/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
3.5%
7/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.1%
48/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
20.3%
41/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.2%
69/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
29.7%
60/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.6%
47/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
18.8%
38/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.8%
37/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
18.8%
38/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.1%
46/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
22.3%
45/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.8%
10/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.6%
45/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
21.8%
44/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.5%
9/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Glucose Intolerance
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
16/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
6.9%
14/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Metabolism and nutrition disorders
Anorexia
|
22.6%
47/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
22.3%
45/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.2%
13/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
5.9%
12/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
9/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Left-Sided
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
3.8%
8/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.5%
24/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
11.4%
23/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
7/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - O
|
4.8%
10/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.0%
8/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Nervous System Disorders - Other
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Tremor
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Stroke
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Presyncope
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.6%
20/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
5.0%
10/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Paresthesia
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Memory Impairment
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Lethargy
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Headache
|
25.5%
53/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
22.8%
46/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Dysgeusia
|
10.1%
21/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
9.4%
19/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Sinus Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Dysarthria
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Syncope
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Dizziness
|
15.9%
33/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
14.4%
29/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Concentration Impairment
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Nervous system disorders
Ataxia
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Psychiatric Disorders - Other
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Suicidal Ideation
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Libido Decreased
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Insomnia
|
11.1%
23/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
16.3%
33/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Depression
|
4.8%
10/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
5.4%
11/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Delirium
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Confusion
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Anxiety
|
11.1%
23/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
13.9%
28/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Psychiatric disorders
Agitation
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other
|
9.6%
20/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
9.4%
19/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Urinary Urgency
|
5.8%
12/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
7.4%
15/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Urinary Retention
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Urinary Incontinence
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.5%
9/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Urinary Tract Pain
|
7.7%
16/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
11.4%
23/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Urinary Frequency
|
15.4%
32/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
19.8%
40/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Urinary Fistula
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Renal Calculi
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
14/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
5.4%
11/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Hematuria
|
6.7%
14/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
7.4%
15/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Cystitis Noninfective
|
11.1%
23/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
17.8%
36/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
3.0%
6/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Vaginal Perforation
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Vaginal Pain
|
3.8%
8/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.5%
9/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
25.0%
52/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
22.3%
45/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Vaginal Fistula
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Uterine Hemorrhage
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Premature Menopause
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Perineal Pain
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Pelvic Pain
|
18.8%
39/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
14.4%
29/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
12.0%
25/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
15.8%
32/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Genital Edema
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.9%
4/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
1.5%
3/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
14/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
9.9%
20/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
15/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
6.9%
14/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
7.2%
15/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
5.0%
10/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.0%
8/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
8/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.5%
5/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
4.3%
9/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.0%
8/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.99%
2/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.4%
5/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.0%
8/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Body Odor
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
10/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.0%
8/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
0.96%
2/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Vascular Disorders - Other
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Thromboembolic Event
|
3.8%
8/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
4.5%
9/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Superficial Thrombophlebitis
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Phlebitis
|
0.48%
1/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.00%
0/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Hypotension
|
2.9%
6/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
3.5%
7/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Hypertension
|
12.0%
25/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
10.9%
22/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Hot Flashes
|
13.5%
28/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
9.4%
19/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Hematoma
|
0.00%
0/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
0.50%
1/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
|
Vascular disorders
Flushing
|
1.4%
3/208 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
2.0%
4/202 • All Adverse Events (AEs) occurring during treatment period (median: 53 days) and up to 30 days after stopping the study treatment for participants who received any study treatment. All-cause mortality that occurred through study completion with a median follow-up as 28 months (inter-quartile range: 15 to 45 months) by reverse Kaplan-Meier method.
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment for participants who received any study treatment. Note that the population is different for all-cause mortality and adverse events. For all-cause mortality the population is "all eligible participants." For adverse event reporting, the population is "all patients who received any study treatment."
|
Additional Information
Christopher Purdy on behalf of Wei Deng, PhD
NRG Oncology
Phone: (716) 845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60