Trial Outcomes & Findings for Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT02085408)
NCT ID: NCT02085408
Last Updated: 2024-12-13
Results Overview
Overall survival is defined as the time from randomization to death or date last known alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
727 participants
Primary outcome timeframe
Assessed every 3 months for 4 years and then every 6 months for 1 year
Results posted on
2024-12-13
Participant Flow
This study was activated on December 28, 2010, accrued its first patient on February 4, 2011, and closed on January 24, 2019 for a total of 727 patients enrolled.
Participant milestones
| Measure |
A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant)
Patients in Arm A who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Cytarabine; Arm C).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation (Arm G).
|
B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant)
Patients in Arm B who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Clofarabine; Arm D).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Clofarabine; Arm D) followed by allogeneic stem cell transplantation (Arm G).
|
|---|---|---|
|
Step 1: Induction
STARTED
|
363
|
364
|
|
Step 1: Induction
Adverse Event Data Available
|
356
|
360
|
|
Step 1: Induction
Donor Information Available
|
191
|
195
|
|
Step 1: Induction
COMPLETED
|
227
|
225
|
|
Step 1: Induction
NOT COMPLETED
|
136
|
139
|
|
Step 2: Consolidation
STARTED
|
174
|
154
|
|
Step 2: Consolidation
Adverse Event Data Available
|
170
|
148
|
|
Step 2: Consolidation
COMPLETED
|
129
|
104
|
|
Step 2: Consolidation
NOT COMPLETED
|
45
|
50
|
|
Step 3: Maintenance
STARTED
|
103
|
89
|
|
Step 3: Maintenance
Randomized to Observation
|
35
|
26
|
|
Step 3: Maintenance
Randomized to Decitabine
|
32
|
27
|
|
Step 3: Maintenance
Received Transplant
|
36
|
36
|
|
Step 3: Maintenance
COMPLETED
|
78
|
67
|
|
Step 3: Maintenance
NOT COMPLETED
|
25
|
22
|
Reasons for withdrawal
| Measure |
A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant)
Patients in Arm A who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Cytarabine; Arm C).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation (Arm G).
|
B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant)
Patients in Arm B who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Clofarabine; Arm D).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Clofarabine; Arm D) followed by allogeneic stem cell transplantation (Arm G).
|
|---|---|---|
|
Step 1: Induction
Disease Progression
|
19
|
19
|
|
Step 1: Induction
Adverse Event
|
18
|
17
|
|
Step 1: Induction
Death
|
33
|
30
|
|
Step 1: Induction
Withdrawal by Subject
|
16
|
8
|
|
Step 1: Induction
Alternative Therapy
|
15
|
19
|
|
Step 1: Induction
Complicating Disease
|
2
|
3
|
|
Step 1: Induction
Other
|
27
|
39
|
|
Step 1: Induction
Never started treatment
|
6
|
4
|
|
Step 2: Consolidation
Disease Progression
|
5
|
20
|
|
Step 2: Consolidation
Adverse Event
|
9
|
8
|
|
Step 2: Consolidation
Death
|
4
|
3
|
|
Step 2: Consolidation
Withdrawal by Subject
|
8
|
5
|
|
Step 2: Consolidation
Alternative Therapy
|
9
|
3
|
|
Step 2: Consolidation
Complicating Disease
|
0
|
2
|
|
Step 2: Consolidation
Other
|
6
|
6
|
|
Step 2: Consolidation
Never started treatment
|
4
|
3
|
|
Step 3: Maintenance
Disease Progression
|
13
|
11
|
|
Step 3: Maintenance
Adverse Event
|
2
|
4
|
|
Step 3: Maintenance
Death
|
1
|
2
|
|
Step 3: Maintenance
Alternative Therapy
|
1
|
1
|
|
Step 3: Maintenance
Complicating Disease
|
0
|
1
|
|
Step 3: Maintenance
Other
|
3
|
2
|
|
Step 3: Maintenance
Never started treatment
|
5
|
1
|
Baseline Characteristics
Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant)
n=363 Participants
Patients in Arm A who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Cytarabine; Arm C).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation (Arm G).
|
B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant)
n=364 Participants
Patients in Arm B who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Clofarabine; Arm D).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Clofarabine; Arm D) followed by allogeneic stem cell transplantation (Arm G).
|
Total
n=727 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
68 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
414 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
306 Participants
n=5 Participants
|
295 Participants
n=7 Participants
|
601 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
334 Participants
n=5 Participants
|
328 Participants
n=7 Participants
|
662 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for 4 years and then every 6 months for 1 yearPopulation: All randomized patients are included in this analysis.
Overall survival is defined as the time from randomization to death or date last known alive.
Outcome measures
| Measure |
A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant)
n=363 Participants
Patients in Arm A who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Cytarabine; Arm C).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation (Arm G).
|
B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant)
n=364 Participants
Patients in Arm B who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Clofarabine; Arm D).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Clofarabine; Arm D) followed by allogeneic stem cell transplantation (Arm G).
|
|---|---|---|
|
Overall Survival
|
12.9 months
Interval 11.0 to 14.9
|
11.6 months
Interval 9.8 to 14.1
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 4 years and then every 6 months for 1 yearPopulation: All randomized patients are included in this analysis.
Patients are required to have all of the following to be considered as having a completion remission (CR). * Peripheral Blood Counts 1. Neutrophil count \> 1.0 x 10\^9 /L 2. Platelet count ≥ 100 x 10\^9 /L 3. Reduced hemoglobin concentration or hematocrit has no bearing on remission status 4. Leukemic blasts must not be present in the peripheral blood * Bone Marrow Aspirate and Biopsy 1. Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines 2. \< 5% blasts by morphologic review 3. Auer rods must not be detectable * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present
Outcome measures
| Measure |
A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant)
n=363 Participants
Patients in Arm A who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Cytarabine; Arm C).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation (Arm G).
|
B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant)
n=364 Participants
Patients in Arm B who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Clofarabine; Arm D).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Clofarabine; Arm D) followed by allogeneic stem cell transplantation (Arm G).
|
|---|---|---|
|
Proportion of Patients With Complete Remission
|
0.446 proportion of participants
Interval 0.394 to 0.499
|
0.453 proportion of participants
Interval 0.401 to 0.506
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 4 years and then every 6 months for 1 yearPopulation: Patients with transplant donor information (either had donor or did not have a donor) reported after achieving CR/Cri/leukemia-free state post induction therapy
Overall survival is defined as time between achieving leukemia-free state after induction therapy to death from any cause or date last known alive. The association between overall survival and donor status was evaluated regardless of assigned treatment arms. Patients with transplant donor information (either had donor or did not have a donor) reported after achieving CR/Cri/leukemia-free state post induction therapy were included in this analysis.
Outcome measures
| Measure |
A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant)
n=172 Participants
Patients in Arm A who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Cytarabine; Arm C).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation (Arm G).
|
B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant)
n=214 Participants
Patients in Arm B who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Clofarabine; Arm D).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Clofarabine; Arm D) followed by allogeneic stem cell transplantation (Arm G).
|
|---|---|---|
|
Overall Survival by Donor Status
|
27.2 months
Interval 15.3 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
12.9 months
Interval 10.3 to 17.0
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 4 years and then every 6 months for 1 yearPopulation: Only patients who remained in CR or CRi after completion of consolidation therapy that were randomized to either observation or decitabine in the maintenance step were included in this analysis.
DFS for maintenance comparison is defined as the time from maintenance randomization until relapse or death of any cause. The censored follow-up time for patients without relapse and death information is the date of last contact. Only patients who remained in CR or CRi after completion of consolidation therapy that were randomized to either observation or decitabine in the maintenance Step were included in this analysis.
Outcome measures
| Measure |
A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant)
n=61 Participants
Patients in Arm A who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Cytarabine; Arm C).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation (Arm G).
|
B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant)
n=59 Participants
Patients in Arm B who achieve a CR or CRi after induction therapy (Step 1) proceed to consolidation therapy (Step 2 - Clofarabine; Arm D).
Patients who remain in CR or CRi after completion of consolidation therapy are randomized to one of the two maintenance therapy (Step 3) arms (Arm E: observation or Arm F: Decitabine).
Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Clofarabine; Arm D) followed by allogeneic stem cell transplantation (Arm G).
|
|---|---|---|
|
Disease-free Survival for Maintenance
|
8.2 months
Interval 5.1 to 18.7
|
16.3 months
Interval 10.1 to 26.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of maintenance treatmentDNA methylation profiling and gene expression are evaluated using peripheral blood samples collected at baseline of the maintenance treatment (prior to 2nd randomization). These are to be compared between patients with decitabine and patients on observation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 4 years and then every 6 months for 1 yearTo examine the epigenetic profiles of remission marrow among patients randomized to observation vs. decitabine to determine whether epigenetic signature of apparently morphologically normal bone marrow is predictive of relapse or response to decitabine maintenance. Relapse following complete remission is defined as: 1. Peripheral Blood Counts * Reappearance of blasts in the blood 2. Bone Marrow Aspirate and Biopsy * Presence of \> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 4 years and then every 6 months for 1 yearPatients with all the following are considered as having a complete remission. * Peripheral Blood Counts 1. Neutrophil count \> 1.0 x 109 /L 2. Platelet count ≥ 100 x 109 /L 3. Reduced hemoglobin concentration or hematocrit has no bearing on remission status 4. Leukemic blasts must not be present in the peripheral blood * Bone Marrow Aspirate and Biopsy 1. Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines 2. \< 5% blasts by morphologic review 3. Auer rods must not be detectable * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present The proportion of patients with complete remission will be compared between patients who overexpress Pgp and patients who do not overexpress Pgp.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineExpression of CXCR4 will be assessed in this study by flow cytometric assay. The associations between the expression level and other prognostic factors in patients receiving induction treatment will be evaluated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 4 years and then every 6 months for 1 yearRelapse following complete remission is defined as: 1. Peripheral Blood Counts * Reappearance of blasts in the blood 2. Bone Marrow Aspirate and Biopsy * Presence of \> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 3 months for 4 years and then every 6 months for 1 yearOverall survival is defined as time from randomization to death or date last known alive. The associations between overall survival and smoking status, obesity, regular acetaminophen use, regular aspirin use, benzene exposure, living in a rural/farm environment and some other underlying exposures and lifestyle factors will be evaluated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineCopy number changes will be tested based on array CGH technology. The associations between copy number changes and acute myeloid leukemia patient characteristics will be evaluated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatmentQOL will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu). This instrument combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatmentQOL will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu). This instrument combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. Changes in QOL will be calculated by subtracting baseline QOL score from follow-up QOL score.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baselineQOL will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G). FACT-G includes 4 subscales, physical well-being (score range: 0-28), social/family well-being (score range: 0-28), emotional well-being (score range: 0-24), and functional well-being (score range: 0-28). The total score of FACT-G ranges between 0 and 108. Higher score indicates better QOL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed prior to transplant and 100 days after transplantFor those patients who go to allo transplant, the FACT-Leu and the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) instruments will be administered at the beginning of the conditioning regimen and 100 days (+14 days) post transplant. FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. FACIT-Fatigue has 13 items and the total score ranges between 0 and 52. Higher score indicates better QOL. Changes in QOL will be calculated by subtracting baseline QOL score from follow-up QOL score.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baselineThe associations between baseline QOL scores and the ability to finish treatment will be evaluated. Baseline QOL will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) and the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue). FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. FACIT-Fatigue has 13 items and the total score ranges between 0 and 52. Higher score indicates better QOL.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Induction: Daunorubicin + Cytarabine)
Serious events: 354 serious events
Other events: 356 other events
Deaths: 284 deaths
Arm B (Induction: Clofarabine)
Serious events: 357 serious events
Other events: 355 other events
Deaths: 295 deaths
Arm C (Consolidation: Cytarabine)
Serious events: 164 serious events
Other events: 169 other events
Deaths: 0 deaths
Arm D (Consolidation: Clofarabine)
Serious events: 140 serious events
Other events: 147 other events
Deaths: 0 deaths
Arm E (Maintenance: Observation)
Serious events: 19 serious events
Other events: 51 other events
Deaths: 0 deaths
Arm F (Maintenance: Decitabine)
Serious events: 50 serious events
Other events: 53 other events
Deaths: 0 deaths
Arm G (Transplant)
Serious events: 62 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Induction: Daunorubicin + Cytarabine)
n=356 participants at risk
Patients receive daunorubicin intravenously (IV) over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.
Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., \< 5% blasts and \< 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 14.
Patients who achieve a complete remission (CR) or CR with incomplete marrow recovery (CRi) after induction therapy proceed to consolidation therapy (Cytarabine; Arm C). Patients who achieve a "morphologic leukemia-free state" after induction therapy and who have an HLA-identical donor proceed to consolidation therapy followed by allogeneic stem cell transplantation.
|
Arm B (Induction: Clofarabine)
n=360 participants at risk
Patients receive clofarabine IV over 1 hour on days 1-5. Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., \< 5% blasts and \< 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 21 and no later than day 56.
Patients who achieve a complete remission (CR) or CR with incomplete marrow recovery (CRi) after induction therapy proceed to consolidation therapy (Clofarabine; Arm D). Patients who achieve a "morphologic leukemia-free state" after induction therapy and who have an HLA-identical donor proceed to consolidation therapy followed by allogeneic stem cell transplantation.
|
Arm C (Consolidation: Cytarabine)
n=170 participants at risk
Patients in Arm A who achieve a CR or CRi after induction therapy proceed to consolidation therapy (Cytarabine; Arm C). Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation.
Patients receive cytarabine (consolidation therapy) IV over 1 hour once or twice daily on days 1-6. Treatment repeats every 4-6 weeks for 2 courses.
|
Arm D (Consolidation: Clofarabine)
n=148 participants at risk
Patients in Arm B who achieve a CR or CRi after induction therapy proceed to consolidation therapy (Clofarabine; Arm D). Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Consolidation; Arm D) followed by allogeneic stem cell transplantation.
Patients receive clofarabine (consolidation therapy) IV over 1 hour on days 1-5. Treatment repeats every 4-6 weeks for 2 courses.
|
Arm E (Maintenance: Observation)
n=59 participants at risk
Patients in Arms C or D who remain in CR or CRi after completion of consolidation therapy are randomized to maintenance therapy (Observation; Arm E).
Patients undergo observation monthly for 12 months.
|
Arm F (Maintenance: Decitabine)
n=54 participants at risk
Patients in Arms C or D who remain in CR or CRi after completion of consolidation therapy are randomized to maintenance therapy (Decitabine; Arm F).
Patients receive decitabine IV over 1 hour on days 1-3. Treatment repeats every 4 weeks for 12 months the absence of unacceptable toxicity.
|
Arm G (Transplant)
n=70 participants at risk
Patients in Arms C or D who achieve a CR or CRi or a "morphologic leukemia-free state" after completion of consolidation therapy and who have an HLA-identical donor proceed to allogeneic stem cell transplantation. (Arm G).
Patients undergo allogeneic peripheral blood stem cell transplantation
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
21/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.3%
19/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
24/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.8%
28/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.8%
3/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.1%
6/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
2/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.3%
3/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
23/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.9%
14/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
5/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.4%
37/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.2%
26/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.4%
5/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Ear and labyrinth disorders
Ear pain
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Anemia
|
86.5%
308/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
84.4%
304/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
69.4%
118/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
52.0%
77/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
1/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
16.7%
9/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
30.0%
21/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
67.1%
239/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
55.3%
199/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
40.0%
68/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
17.6%
26/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
9.3%
5/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
30.0%
21/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Blood and lymphatic system disorders
Blood and lymphatic disorders - Other
|
1.7%
6/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
5/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
14/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
7/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Cardiac arrest
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Heart failure
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.1%
4/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.0%
7/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Pericarditis
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Sinus bradycardia
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
5/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
4/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Death NOS
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Edema limbs
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Fatigue
|
7.0%
25/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.0%
18/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.9%
10/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.7%
4/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.7%
2/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.3%
3/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Fever
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
4/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Localized edema
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Multi-organ failure
|
1.7%
6/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.1%
4/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Pain
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
General and administration site - Other
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
20/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.4%
23/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.8%
3/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.0%
3/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.3%
3/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue - Other
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.1%
4/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
4/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
7.3%
26/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.6%
13/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.1%
7/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.7%
2/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
8.6%
6/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
4/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Esophagitis
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.7%
13/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.1%
5/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
8/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
8/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
5/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.1%
5/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Oral pain
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Rectal pain
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Typhlitis
|
2.2%
8/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
4/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
2/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Immune system disorders
Allergic reaction
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Immune system disorders
Cytokine release syndrome
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Bladder infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Bone infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Catheter related infection
|
4.2%
15/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.4%
16/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.9%
10/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.0%
3/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Endocarditis infective
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Enterocolitis infectious
|
2.8%
10/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
8/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.8%
3/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Esophageal infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Eye infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Gallbladder infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Joint infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Lip infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Lung infection
|
16.9%
60/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.7%
42/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.8%
20/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.7%
4/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.7%
2/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
2/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Mucosal infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Papulopustular rash
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Peritoneal infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Pleural infection
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Rash pustular
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Scrotal infection
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Sepsis
|
11.0%
39/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.5%
27/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
12.9%
22/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.7%
4/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.3%
3/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Sinusitis
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Skin infection
|
2.2%
8/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
5/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
4/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
1/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Soft tissue infection
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Splenic infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Stoma site infection
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Upper respiratory infection
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
12/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.3%
12/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.7%
2/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
2/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Wound infection
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Infections and infestations - Other
|
7.0%
25/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.3%
19/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.9%
10/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.7%
4/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Activated PTT prolonged
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Alanine aminotransferase increased
|
3.9%
14/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
21.9%
79/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.1%
7/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
8.8%
13/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Alkaline phosphatase increased
|
2.5%
9/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
6/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.8%
3/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
19/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
22.2%
80/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.1%
7/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.1%
15/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.7%
2/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.3%
3/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Blood bilirubin increased
|
8.1%
29/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.6%
38/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.1%
7/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.0%
3/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
1/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
2/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
CO diffusing capacity decreased
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Cardiac troponin I increased
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
CD4 lymphocytes decreased
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Creatinine increased
|
3.4%
12/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.6%
13/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
4/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
1/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.3%
3/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Ejection fraction decreased
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
ECG QT corrected interval prolonged
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.8%
3/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
GGT increased
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
1/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Hemoglobin increased
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Lipase increased
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Lymphocyte count decreased
|
24.4%
87/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
23.1%
83/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
25.9%
44/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
25.7%
38/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
1/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.4%
4/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
24.3%
17/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Lymphocyte count increased
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Neutrophil count decreased
|
96.3%
343/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
94.2%
339/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
83.5%
142/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
83.8%
124/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.9%
7/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
88.9%
48/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
64.3%
45/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Platelet count decreased
|
97.2%
346/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
96.4%
347/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
90.6%
154/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
85.1%
126/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
13.6%
8/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
42.6%
23/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
57.1%
40/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Urine output decreased
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Weight gain
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Weight loss
|
1.4%
5/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.8%
3/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
White blood cell decreased
|
98.0%
349/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
97.5%
351/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
87.6%
149/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
85.1%
126/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.8%
4/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
72.2%
39/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
74.3%
52/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Investigations - Other, specify
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.1%
4/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.8%
3/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.8%
35/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.2%
15/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.5%
6/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.0%
7/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
8/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
5/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.7%
4/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
2/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
17/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.1%
11/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.5%
11/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.7%
2/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
8.6%
6/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.0%
7/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.1%
4/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.5%
9/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.5%
9/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
4/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.9%
14/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.5%
9/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.7%
8/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective - Other
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Encephalopathy
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Headache
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Stroke
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Syncope
|
1.4%
5/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.1%
4/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Vasovagal reaction
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.7%
1/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Eye disorders
Eye pain
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Eye disorders
Uveitis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Eye disorders
Vitreous hemorrhage
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Psychiatric disorders
Anxiety
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Psychiatric disorders
Confusion
|
1.4%
5/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Psychiatric disorders
Depression
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Psychiatric disorders
Insomnia
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.7%
6/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
23/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.6%
20/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.4%
4/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
2/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
5/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.2%
8/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.9%
2/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.56%
2/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.1%
18/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.0%
18/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.2%
8/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
5/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.9%
14/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.5%
9/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.59%
1/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory thoracic mediastinal - Other
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.68%
1/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.9%
14/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.2%
15/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.8%
3/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.2%
2/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Renal and urinary disorders
Hematuria
|
0.84%
3/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.28%
1/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Capillary leak syndrome
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.28%
1/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Hematoma
|
0.56%
2/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Hypertension
|
4.2%
15/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
3.3%
12/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.1%
7/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Hypotension
|
5.3%
19/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.0%
18/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.7%
8/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
2/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Vascular disorders
Thromboembolic event
|
1.4%
5/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.83%
3/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.9%
1/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
Other adverse events
| Measure |
Arm A (Induction: Daunorubicin + Cytarabine)
n=356 participants at risk
Patients receive daunorubicin intravenously (IV) over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.
Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., \< 5% blasts and \< 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 14.
Patients who achieve a complete remission (CR) or CR with incomplete marrow recovery (CRi) after induction therapy proceed to consolidation therapy (Cytarabine; Arm C). Patients who achieve a "morphologic leukemia-free state" after induction therapy and who have an HLA-identical donor proceed to consolidation therapy followed by allogeneic stem cell transplantation.
|
Arm B (Induction: Clofarabine)
n=360 participants at risk
Patients receive clofarabine IV over 1 hour on days 1-5. Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., \< 5% blasts and \< 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 21 and no later than day 56.
Patients who achieve a complete remission (CR) or CR with incomplete marrow recovery (CRi) after induction therapy proceed to consolidation therapy (Clofarabine; Arm D). Patients who achieve a "morphologic leukemia-free state" after induction therapy and who have an HLA-identical donor proceed to consolidation therapy followed by allogeneic stem cell transplantation.
|
Arm C (Consolidation: Cytarabine)
n=170 participants at risk
Patients in Arm A who achieve a CR or CRi after induction therapy proceed to consolidation therapy (Cytarabine; Arm C). Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm A and who have an HLA-identical donor proceed to consolidation therapy (Cytarabine; Arm C) followed by allogeneic stem cell transplantation.
Patients receive cytarabine (consolidation therapy) IV over 1 hour once or twice daily on days 1-6. Treatment repeats every 4-6 weeks for 2 courses.
|
Arm D (Consolidation: Clofarabine)
n=148 participants at risk
Patients in Arm B who achieve a CR or CRi after induction therapy proceed to consolidation therapy (Clofarabine; Arm D). Patients who achieve a "morphologic leukemia-free state" after induction therapy in Arm B and who have an HLA-identical donor proceed to consolidation therapy (Consolidation; Arm D) followed by allogeneic stem cell transplantation.
Patients receive clofarabine (consolidation therapy) IV over 1 hour on days 1-5. Treatment repeats every 4-6 weeks for 2 courses.
|
Arm E (Maintenance: Observation)
n=59 participants at risk
Patients in Arms C or D who remain in CR or CRi after completion of consolidation therapy are randomized to maintenance therapy (Observation; Arm E).
Patients undergo observation monthly for 12 months.
|
Arm F (Maintenance: Decitabine)
n=54 participants at risk
Patients in Arms C or D who remain in CR or CRi after completion of consolidation therapy are randomized to maintenance therapy (Decitabine; Arm F).
Patients receive decitabine IV over 1 hour on days 1-3. Treatment repeats every 4 weeks for 12 months the absence of unacceptable toxicity.
|
Arm G (Transplant)
n=70 participants at risk
Patients in Arms C or D who achieve a CR or CRi or a "morphologic leukemia-free state" after completion of consolidation therapy and who have an HLA-identical donor proceed to allogeneic stem cell transplantation. (Arm G).
Patients undergo allogeneic peripheral blood stem cell transplantation
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
91.9%
327/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
90.8%
327/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
95.3%
162/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
95.3%
141/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
67.8%
40/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
88.9%
48/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
84.3%
59/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Alanine aminotransferase increased
|
45.2%
161/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
70.8%
255/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
45.3%
77/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
53.4%
79/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.2%
6/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
22.2%
12/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
34.3%
24/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Alkaline phosphatase increased
|
42.4%
151/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
46.1%
166/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
45.9%
78/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
40.5%
60/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
15.3%
9/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
13.0%
7/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
22.9%
16/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
50.3%
179/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
72.8%
262/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
42.4%
72/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
50.7%
75/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
8.5%
5/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
25.9%
14/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
31.4%
22/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Blood bilirubin increased
|
44.7%
159/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
59.2%
213/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
33.5%
57/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
29.7%
44/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.1%
3/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
16.7%
9/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
18.6%
13/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Creatinine increased
|
28.7%
102/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
25.8%
93/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
17.1%
29/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
16.2%
24/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.8%
4/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
18.5%
10/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
22.9%
16/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Neutrophil count decreased
|
54.2%
193/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
54.4%
196/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
54.7%
93/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
57.4%
85/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
18.6%
11/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
83.3%
45/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
51.4%
36/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Platelet count decreased
|
80.1%
285/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
78.6%
283/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
91.8%
156/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
90.5%
134/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
61.0%
36/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
92.6%
50/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
72.9%
51/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
White blood cell decreased
|
70.8%
252/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
74.2%
267/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
84.1%
143/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
81.8%
121/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
49.2%
29/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
94.4%
51/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
65.7%
46/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
13.8%
49/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.7%
42/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.1%
7/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
6.8%
10/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
39.3%
140/356 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
33.9%
122/360 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
45.3%
77/170 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
31.8%
47/148 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
10.2%
6/59 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.1%
6/54 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
51.4%
36/70 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60