Trial Outcomes & Findings for An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib (NCT NCT03952039)
NCT ID: NCT03952039
Last Updated: 2025-08-28
Results Overview
Percentage of participants who have ≥ 35% spleen volume reduction (SVR) at end of cycle 6 A Cochran-Mantel-Haenszel (CMH) test to adjust for planned stratification factors (spleen size by palpation, platelet counts and refractory/relapsed or intolerance to ruxolitinib treatment). The RRs and 95% confidence intervals (CI) will be provided for each arm as well as for the difference in RRs and 95% confidence interval of the difference for fedratinib to BAT.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
From Screening to end of Cycle 6 (1 cycle = 28 days), approximately 196 days
Results posted on
2025-08-28
Participant Flow
201 participants randomized and treated
Participant milestones
| Measure |
Fedratinib
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
67
|
|
Overall Study
Participants Who Crossed Over
|
0
|
46
|
|
Overall Study
COMPLETED
|
43
|
28
|
|
Overall Study
NOT COMPLETED
|
91
|
39
|
Reasons for withdrawal
| Measure |
Fedratinib
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Overall Study
Adverse Event
|
22
|
8
|
|
Overall Study
Withdrawal by Participant
|
17
|
12
|
|
Overall Study
Death
|
13
|
6
|
|
Overall Study
Lack of Efficacy
|
12
|
2
|
|
Overall Study
Physician Decision
|
9
|
3
|
|
Overall Study
Progressive Disease
|
6
|
4
|
|
Overall Study
Other Reasons
|
12
|
4
|
Baseline Characteristics
An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
Baseline characteristics by cohort
| Measure |
Fedratinib
n=134 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.7 Years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
67.6 Years
STANDARD_DEVIATION 8.16 • n=7 Participants
|
68.4 Years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 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
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Screening to end of Cycle 6 (1 cycle = 28 days), approximately 196 daysPopulation: Intent to Treat Population
Percentage of participants who have ≥ 35% spleen volume reduction (SVR) at end of cycle 6 A Cochran-Mantel-Haenszel (CMH) test to adjust for planned stratification factors (spleen size by palpation, platelet counts and refractory/relapsed or intolerance to ruxolitinib treatment). The RRs and 95% confidence intervals (CI) will be provided for each arm as well as for the difference in RRs and 95% confidence interval of the difference for fedratinib to BAT.
Outcome measures
| Measure |
Fedratinib
n=134 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Spleen Volume Response Rate (RR)
|
35.8 Percentage of Participants
Interval 27.7 to 44.6
|
6.0 Percentage of Participants
Interval 1.7 to 14.6
|
SECONDARY outcome
Timeframe: From Cycle 1 Dose 1 to end of Cycle 6, approximately 168 daysPopulation: ITT population with non-zero baseline TSS
Percentage of participants with ≥ 50% reduction in total symptom scores measured by Myelofibrosis Symptom Assessment Form (MFSAF) 4.0 at end of cycle 6. Subjects with a missing TSS at the end of cycle 6 or who had disease progression before the end of the cycle 6 will be considered non-responders. MFSAF measures the sum of 7 symptoms on a scale from 0 to 10 (0 being absent and 10 being the worst imagineable). The lower the score the better. A Cochran-Mantel-Haenszel (CMH) test to adjust for planned stratification factors (spleen size by palpation, platelet counts and refractory/relapsed or intolerance to ruxolitinib treatment). The SRRs and 95% confidence intervals (CI) will be provided for each arm as well as for the difference in SRRs and 95% confidence interval of the difference for fedratinib to BAT.
Outcome measures
| Measure |
Fedratinib
n=126 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=65 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Symptom Response Rate (SRR)
|
34.1 Percentage of Participants
Interval 25.9 to 43.1
|
16.9 Percentage of Participants
Interval 8.8 to 28.3
|
SECONDARY outcome
Timeframe: From Screening to end of Cycle 6 (1 cycle = 28 days), approximately 196 daysPopulation: Intent to Treat Population
Percentage of participants who have ≥ 25% spleen volume reduction (SVR) at end of cycle 6 A Cochran-Mantel-Haenszel (CMH) test to adjust for planned stratification factors (spleen size by palpation, platelet counts and refractory/relapsed or intolerance to ruxolitinib treatment). The RRs and 95% confidence intervals (CI) will be provided for each arm as well as for the difference in RRs and 95% confidence interval of the difference for fedratinib to BAT.
Outcome measures
| Measure |
Fedratinib
n=134 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Spleen Volume Response Rate (RR25)
|
47.0 Percentage of Participants
Interval 38.3 to 55.8
|
13.4 Percentage of Participants
Interval 6.3 to 24.0
|
SECONDARY outcome
Timeframe: From Cycle 1 Dose 1 to end of Cycle 6, approximately 168 daysPopulation: Safety Population
Number of participants with all grade adverse events (AEs) and grade 3 to 4 AEs
Outcome measures
| Measure |
Fedratinib
n=134 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Number of Participants With All Grade Treatment Emergent Adverse Events (AEs) and Grade 3 to 4 Treatment Emergent AEs
All Grade AEs
|
132 Participants
|
65 Participants
|
|
Number of Participants With All Grade Treatment Emergent Adverse Events (AEs) and Grade 3 to 4 Treatment Emergent AEs
Grade 3 and 4 AEs
|
88 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: From Cycle 1 Dose 1 to end of Cycle 6, approximately 168 daysPopulation: Safety Population
Number of participants with hematology laboratory abnormalities in the following parameters: hemoglobin (decreased), leukocytes (increase and decrease), lymphocytes (decreased), neutrophils (segmented and band form decreased), Platelets (decreased).
Outcome measures
| Measure |
Fedratinib
n=134 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities
Hemoglobin Decreased All Grades
|
129 Participants
|
64 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Hemoglobin Decreased Grade 3
|
62 Participants
|
20 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Hemoglobin Decreased Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Leukocytes Decreased All Grades
|
41 Participants
|
19 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Leukocytes Decreased Grade 3
|
8 Participants
|
3 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Leukocytes Decreased Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Leukocytes Increased All Grades
|
4 Participants
|
4 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Leukocytes Increased Grade 3
|
4 Participants
|
4 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Leukocytes Increased Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Lymphocytes Decreased All Grades
|
49 Participants
|
20 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Platelets Decreased Grade 4
|
3 Participants
|
2 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Lymphocytes Decreased Grade 3
|
20 Participants
|
7 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Lymphocytes Decreased Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Neutrophils, segmented and band from decreased All Grades
|
34 Participants
|
15 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Neutrophils, segmented and band from decreased Grade 3
|
11 Participants
|
4 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Neutrophils, segmented and band from decreased Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Platelets Decreased All Grades
|
73 Participants
|
43 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Platelets Decreased Grade 3
|
24 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From Cycle 1 Dose 1 to end of Cycle 6, approximately 168 daysPopulation: Intent to Treat Population with baseline spleen size ≥5 cm below the lower costal margin (LCM)
Spleen response rate by palpation is the percentage of participants at the end of cycle 6 with a spleen response according to the IWG-MRT 2013 criteria. A baseline splenomegaly that is palpable at 5-10 cm, below the LCM, becomes not palpable\*\* or A baseline splenomegaly that is palpable at \> 10 cm, below the LCM, decreases by ≥ 50%\*\* Participants with a missing spleen size assessment at the end of cycle 6 including those who meet the criteria for progression of splenomegaly before end of cycle 6 will be considered not to be responders.
Outcome measures
| Measure |
Fedratinib
n=134 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=65 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Spleen Response Rate by Palpation (RRP)
|
28.4 Percentage of Participants
Interval 20.9 to 36.8
|
7.7 Percentage of Participants
Interval 2.5 to 17.0
|
SECONDARY outcome
Timeframe: From baseline to end of treatment visit, Approximately on average 53 weeks up to 151 weeks.Population: Participants with spleen volume response at any time
Durability of spleen volume response (DR) by MRI/CT is defined as the date from the first documented spleen response (ie, ≥ 35% reduction in spleen volume) to the date of subsequent progressive disease (PD) in spleen volume per the IWG-MRT 2013 criteria or death, whichever is earlier. In the absence of an event before the analysis is performed, the DR will be censored at the date of the last valid assessment performed before the analysis performed date.
Outcome measures
| Measure |
Fedratinib
n=72 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=8 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Durability of Spleen Volume Response (DR)
|
86.3 Weeks
Interval 63.0 to 126.4
|
NA Weeks
Median, lower limit number and upper limit number are not estimable due to an insufficient number of events needed to calculate via KM methodology.
|
SECONDARY outcome
Timeframe: From baseline to end of treatment visit, Approximately on average 53 weeks up to 151 weeks.Population: Participants with spleen response by palpation at any time
Durability of spleen response by palpation (DRP) is defined as time from the date of the first documented palpable spleen response, according to the IWG-MRT 2013 to the date of the subsequent PD in spleen size according to the IWG-MRT 2013 or death, whichever is earlier. Durability of spleen response by palpation according to the IWG-MRT 2013 criteria will be calculated for subjects that have an enlarged spleen at baseline (≥ 5 cm below LCM), and that have a spleen response by palpation. In the absence of an event before the analysis is performed, the DRP will be censored at the date of the last valid assessment performed before the analysis performed date.
Outcome measures
| Measure |
Fedratinib
n=71 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=11 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Durability of Spleen Response by Palpation (DRP)
|
118.3 Weeks
Interval 76.0 to
The upper limit number is not estimable due to an insufficient number of events needed to calculate via KM methodology.
|
47.1 Weeks
Interval 21.7 to
The upper limit number is not estimable due to an insufficient number of events needed to calculate via KM methodology.
|
SECONDARY outcome
Timeframe: From baseline to end of treatment visit, Approximately on average 53 weeks up to 151 weeks.Population: Participants with a symptom response at any time
The DSR is defined as time from the first documented response in TSS (ie, reduction in TSS ≥ 50%) measured by MFSAF version 4.0 to the first documented TSS reduction \< 50%. In the absence of TSS reduction \< 50% before the analysis performed, the DSR will be censored at the date of the last valid assessment performed before the analysis performed date.
Outcome measures
| Measure |
Fedratinib
n=90 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=32 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Durability of Symptoms Response (DSR)
|
12.1 Weeks
Interval 8.1 to 16.1
|
10.1 Weeks
Interval 4.1 to 16.7
|
SECONDARY outcome
Timeframe: From Screening to end of Cycle 6 (1 cycle = 28 days), approximately 196 daysPopulation: Safety Population
Number of participants with a CTCAE Grade ≥3 of nausea, diarrhea, or vomiting and any grade wernickes encephalopathy.
Outcome measures
| Measure |
Fedratinib
n=134 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Assessment of the Effectiveness of Risk Mitigation Strategy for ≥3 Grade Gastrointestinal Adverse Events and Any Grade Wernickes Encephalopathy
≥3 grade Diarrhea
|
2 Participants
|
0 Participants
|
|
Assessment of the Effectiveness of Risk Mitigation Strategy for ≥3 Grade Gastrointestinal Adverse Events and Any Grade Wernickes Encephalopathy
≥3 grade Nausea
|
1 Participants
|
0 Participants
|
|
Assessment of the Effectiveness of Risk Mitigation Strategy for ≥3 Grade Gastrointestinal Adverse Events and Any Grade Wernickes Encephalopathy
≥3 grade Vomitting
|
0 Participants
|
0 Participants
|
|
Assessment of the Effectiveness of Risk Mitigation Strategy for ≥3 Grade Gastrointestinal Adverse Events and Any Grade Wernickes Encephalopathy
Any Grade Wernickes Encephalopathy
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Cycle 1 Dose 1 to end of Cycle 6, approximately 168 daysPopulation: Safety Population
Number of participants with thiamine levels below the lower limit of normal
Outcome measures
| Measure |
Fedratinib
n=134 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Number of Participants With Thiamine Levels Below the Lower Limit of Normal
Cycle 1
|
3 Participants
|
0 Participants
|
|
Number of Participants With Thiamine Levels Below the Lower Limit of Normal
Cycle 2
|
13 Participants
|
0 Participants
|
|
Number of Participants With Thiamine Levels Below the Lower Limit of Normal
Cycle 3
|
11 Participants
|
1 Participants
|
|
Number of Participants With Thiamine Levels Below the Lower Limit of Normal
Cycle 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Thiamine Levels Below the Lower Limit of Normal
Cycle 5
|
1 Participants
|
0 Participants
|
|
Number of Participants With Thiamine Levels Below the Lower Limit of Normal
Cycle 6
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from the start of cycle 1 to cycle 7 day 1 approximately 170 days.Population: EORTC QOL-C30 evaluable population
QLQ-C30 - The EORTC QLQ-C30 was developed to assess the quality of life of cancer patients. It consists of 30 items classified into 15 domains including 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); a global QOL subscale; and 6 single items addressing various symptoms and perceived financial impact. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions.
Outcome measures
| Measure |
Fedratinib
n=105 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=50 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Role Functioning
|
8.1 Scores on a Scale
Standard Deviation 34.26
|
12.7 Scores on a Scale
Standard Deviation 40.79
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Emotional Functioning
|
7.0 Scores on a Scale
Standard Deviation 19.63
|
5.6 Scores on a Scale
Standard Deviation 25.86
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Cognitivie Functioning
|
1.7 Scores on a Scale
Standard Deviation 19.83
|
5.6 Scores on a Scale
Standard Deviation 17.74
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Social Functioning
|
6.5 Scores on a Scale
Standard Deviation 29.18
|
0.0 Scores on a Scale
Standard Deviation 27.89
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Fatigue
|
-15.2 Scores on a Scale
Standard Deviation 29.34
|
-16.4 Scores on a Scale
Standard Deviation 33.81
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Nausea and Vomitting
|
-1.7 Scores on a Scale
Standard Deviation 15.32
|
-9.5 Scores on a Scale
Standard Deviation 28.17
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Dyspnea
|
-9.0 Scores on a Scale
Standard Deviation 31.04
|
-22.2 Scores on a Scale
Standard Deviation 35.49
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Insomnia
|
-11.4 Scores on a Scale
Standard Deviation 30.50
|
-7.9 Scores on a Scale
Standard Deviation 25.61
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Appetite Loss
|
-19.5 Scores on a Scale
Standard Deviation 32.84
|
-20.6 Scores on a Scale
Standard Deviation 35.71
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Financial Difficulties
|
3.9 Scores on a Scale
Standard Deviation 21.03
|
1.6 Scores on a Scale
Standard Deviation 12.81
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Global Heath Status
|
10.3 Scores on a Scale
Standard Deviation 27.42
|
13.1 Scores on a Scale
Standard Deviation 26.16
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Physical Functioning
|
8.2 Scores on a Scale
Standard Deviation 19.57
|
11.1 Scores on a Scale
Standard Deviation 26.61
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Pain
|
-12.9 Scores on a Scale
Standard Deviation 25.88
|
-9.5 Scores on a Scale
Standard Deviation 33.57
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Constipation
|
-0.5 Scores on a Scale
Standard Deviation 31.34
|
-9.5 Scores on a Scale
Standard Deviation 35.19
|
|
Mean Change in EORTC QOL-C30 at Cycle 7 Day 1 as Compared With Baseline
Diarrhea
|
5.3 Scores on a Scale
Standard Deviation 27.19
|
6.3 Scores on a Scale
Standard Deviation 17.06
|
SECONDARY outcome
Timeframe: from the start of cycle 1 to cycle 7 day 1 approximately 170 days.Population: EQ-5D-5L evaluable population
EQ-5D-5L - The EQ-5D-5L is a generic, self-administered preference-based measure of health. The five dimensions covered by the EQ-5D-5L include mobility, self-care, pain, usual activities, and anxiety/depression and is converted into a single summary index that can range from -0.594 to 1.0, with a score of 0 indicating death, 1.00 indicating "full health," and negative scores reflecting states perceived to be worse than death. Respondent's self-rated health on a vertical, 0 to 100 scale where 100 = "Best imaginable health state" and 0 = "Worst imaginable health state"
Outcome measures
| Measure |
Fedratinib
n=103 Participants
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=52 Participants
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
|---|---|---|
|
Mean Change From Baseline in EQ-5D-5L Utility Index Score
C2D1
|
0.1086 Scores on a Scale
Standard Deviation 0.20188
|
0.0705 Scores on a Scale
Standard Deviation 0.22881
|
|
Mean Change From Baseline in EQ-5D-5L Utility Index Score
C3D1
|
0.1093 Scores on a Scale
Standard Deviation 0.23950
|
0.1142 Scores on a Scale
Standard Deviation 0.26247
|
|
Mean Change From Baseline in EQ-5D-5L Utility Index Score
C4D1
|
0.1214 Scores on a Scale
Standard Deviation 0.20634
|
0.0366 Scores on a Scale
Standard Deviation 0.26470
|
|
Mean Change From Baseline in EQ-5D-5L Utility Index Score
C5D1
|
0.1068 Scores on a Scale
Standard Deviation 0.21395
|
0.0321 Scores on a Scale
Standard Deviation 0.23607
|
|
Mean Change From Baseline in EQ-5D-5L Utility Index Score
C6D1
|
0.0594 Scores on a Scale
Standard Deviation 0.26864
|
0.0658 Scores on a Scale
Standard Deviation 0.24229
|
|
Mean Change From Baseline in EQ-5D-5L Utility Index Score
C7D1
|
0.0853 Scores on a Scale
Standard Deviation 0.24019
|
0.1066 Scores on a Scale
Standard Deviation 0.25848
|
SECONDARY outcome
Timeframe: From randomization to the End of Survival Follow-upTime from randomization to death due to any reason or disease progression (modified IWG-MRT 2013 including ≥ 25% increase in spleen volume by MRI/CT).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Randomization to the end of Survival Follow UpTime from randomization to death due to any reason
Outcome measures
Outcome data not reported
Adverse Events
Fedratinib
Serious events: 72 serious events
Other events: 128 other events
Deaths: 43 deaths
Best Available Therapy (BAT)
Serious events: 21 serious events
Other events: 57 other events
Deaths: 7 deaths
Fedratinib After Crossover
Serious events: 16 serious events
Other events: 45 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Fedratinib
n=134 participants at risk
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 participants at risk
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
Fedratinib After Crossover
n=46 participants at risk
Fedratinib 400mg/day PO(4x100mg capsules) after crossing over from BAT after cycle 6
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
9/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
2/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
3/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
3.0%
4/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
3/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Right ventricular failure
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Cataract
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Iridocyclitis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Retinal oedema
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Uveitis
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Vitreous haemorrhage
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Melaena
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Subileus
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Exercise tolerance decreased
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
7.5%
10/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
3/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19 pneumonia
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
2/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cholecystitis infective
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Epididymitis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia sepsis
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lower respiratory tract infection
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Neutropenic sepsis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Peritonitis
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
2.2%
3/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
3/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia bacterial
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Postoperative wound infection
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sinusitis
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Soft tissue infection
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tuberculosis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Ejection fraction decreased
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Liver function test abnormal
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Gout
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile cancer
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Sciatica
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Delirium febrile
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
5.2%
7/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal failure
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
3/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Aortic aneurysm
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Haematoma
|
0.00%
0/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Haemorrhage
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Fedratinib
n=134 participants at risk
Fedratinib 400mg/Day PO(4x100mg capsules)
|
Best Available Therapy (BAT)
n=67 participants at risk
Best available therapy regimen (BAT) may include any Investigator-selected treatment and is not limited to approved JAK inhibitors (used according to the prescribing information), chemotherapy (eg, hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgens, interferon, and may also include "no treatment" and symptom directed treatment. BAT may not include investigational agents, fedratinib (if approved during the course of the study) and hematopoietic stem cell transplantation.
|
Fedratinib After Crossover
n=46 participants at risk
Fedratinib 400mg/day PO(4x100mg capsules) after crossing over from BAT after cycle 6
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
41.0%
55/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
35.8%
24/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
41.3%
19/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.0%
4/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
9/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
2/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.8%
48/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.9%
12/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.3%
13/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Conjunctival haemorrhage
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.7%
5/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
11.2%
15/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.4%
9/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.0%
6/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
6/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
5/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
22.4%
30/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.0%
6/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.0%
6/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
46.3%
62/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
3/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.0%
17/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.75%
1/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
40.3%
54/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.9%
10/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.9%
11/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
24/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
3/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.6%
9/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
20.1%
27/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.4%
15/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.4%
8/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
8.2%
11/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.9%
10/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
18.7%
25/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.4%
7/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.0%
6/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
12.7%
17/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.4%
7/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
14.2%
19/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.6%
9/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
6.7%
9/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
3/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
7.5%
10/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
12.7%
17/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Glomerular filtration rate decreased
|
9.0%
12/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Vitamin B1 decreased
|
12.7%
17/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
2/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
6.7%
9/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.7%
17/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.4%
9/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.4%
14/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
9/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.2%
7/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
2/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
6.7%
9/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
8/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
10/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
2/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.5%
10/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.2%
11/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
7/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
3.0%
4/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
11.2%
15/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
5.2%
7/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.2%
7/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal failure
|
4.5%
6/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
10/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
3/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.9%
5/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.7%
17/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.9%
5/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
8/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.0%
4/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
4/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.0%
8/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.4%
9/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.2%
7/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.9%
20/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.9%
10/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.9%
5/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Haematoma
|
1.5%
2/134 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
2/67 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • Adverse Events, Serious Adverse Events and All Cause Mortality: From first dose to database lock: Approximately 3 years and 8 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER