Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises (NCT NCT04935879)
NCT ID: NCT04935879
Last Updated: 2025-12-02
Results Overview
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
241 participants
Primary outcome timeframe
Randomization (Day 1) up to Week 48
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
Inclacumab
Participants with sickle cell disease (SCD) were randomized to receive inclacumab at a dose of 30 milligram/kilogram (mg/kg) intravenously (IV) on Day 1 and once every 12 weeks (Q12W) on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an open-label extension (OLE) study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
122
|
|
Overall Study
Treated
|
118
|
121
|
|
Overall Study
COMPLETED
|
103
|
108
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
Reasons for withdrawal
| Measure |
Inclacumab
Participants with sickle cell disease (SCD) were randomized to receive inclacumab at a dose of 30 milligram/kilogram (mg/kg) intravenously (IV) on Day 1 and once every 12 weeks (Q12W) on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an open-label extension (OLE) study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Pregnancy
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
|
Overall Study
Other
|
3
|
3
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
Baseline characteristics by cohort
| Measure |
Inclacumab
n=119 Participants
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=122 Participants
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.0 Years
STANDARD_DEVIATION 7.14 • n=121 Participants
|
24.6 Years
STANDARD_DEVIATION 8.34 • n=122 Participants
|
24.8 Years
STANDARD_DEVIATION 7.76 • n=243 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=121 Participants
|
63 Participants
n=122 Participants
|
127 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=121 Participants
|
59 Participants
n=122 Participants
|
114 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=121 Participants
|
19 Participants
n=122 Participants
|
37 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=121 Participants
|
102 Participants
n=122 Participants
|
194 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
10 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · African
|
63 Participants
n=121 Participants
|
58 Participants
n=122 Participants
|
121 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
3 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
5 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · Arab
|
1 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
16 Participants
n=121 Participants
|
24 Participants
n=122 Participants
|
40 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · Middle Eastern
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
22 Participants
n=121 Participants
|
25 Participants
n=122 Participants
|
47 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
4 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
7 Participants
n=121 Participants
|
10 Participants
n=122 Participants
|
17 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: Randomization (Day 1) up to Week 48Population: The ITT population included all randomized participants.
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this outcome measure.
Outcome measures
| Measure |
Inclacumab
n=119 Participants
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=122 Participants
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48
|
1.49 Events per 48 weeks
Interval 1.22 to 1.83
|
1.58 Events per 48 weeks
Interval 1.3 to 1.93
|
SECONDARY outcome
Timeframe: Randomization (Day 1) up to Week 48Population: The ITT population included all randomized participants.
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to first VOC was the time between randomization date and onset date of first VOC event during 48 weeks. Kaplan-Meier method was used for estimation.
Outcome measures
| Measure |
Inclacumab
n=119 Participants
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=122 Participants
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Time to First VOC Through Week 48
|
28.7 Weeks
Interval 15.7 to 43.1
|
21.6 Weeks
Interval 17.3 to 28.7
|
SECONDARY outcome
Timeframe: Randomization (Day 1) up to Week 48Population: The ITT population included all randomized participants.
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to second VOC was the time between randomization date and onset date of second VOC event during 48 weeks. Kaplan-Meier method was used for estimation.
Outcome measures
| Measure |
Inclacumab
n=119 Participants
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=122 Participants
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Time to Second VOC Through Week 48
|
NA Weeks
Median, upper and lower limit of 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
|
NA Weeks
Median, upper and lower limit of 95% CI was not estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Randomization (Day 1) up to Week 48Population: The ITT population included all randomized participants.
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Participants without an observed VOC who discontinued the study prior to the end of the 48-week treatment period were assumed to had experienced at least one VOC.
Outcome measures
| Measure |
Inclacumab
n=119 Participants
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=122 Participants
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Percentage of Participants With no VOCs Through Week 48
|
36.0 Percentage of participants
Interval 27.1 to 45.0
|
25.7 Percentage of participants
Interval 17.7 to 33.7
|
SECONDARY outcome
Timeframe: Randomization (Day 1) up to Week 48Population: The ITT population included all randomized participants.
A VOC that required admission to a healthcare facility and treatment with parenteral pain medication where admission included: a hospital admission or an admission to an emergency room, observation unit, or infusion center for \>= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. The rate of VOC was defined as number of VOC events per 48 weeks; rate of VOCs which required admission to a healthcare facility and treatment with parenteral pain medication is presented in this outcome measure.
Outcome measures
| Measure |
Inclacumab
n=119 Participants
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=122 Participants
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48
|
0.85 Events per 48 weeks
Interval 0.65 to 1.1
|
0.83 Events per 48 weeks
Interval 0.64 to 1.08
|
SECONDARY outcome
Timeframe: Randomization (Day 1) up to Week 48Population: The ITT population included all randomized participants.
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility hospitalization. For each VOC event requiring inpatient hospitalization (regardless of treatment received) during the 48-week, the number of days hospitalized were determined based on the hospital admission and discharge dates. The rate of inpatient hospitalization days was defined as number of inpatient hospitalization days for a VOC per 48 weeks and presented in this outcome measure.
Outcome measures
| Measure |
Inclacumab
n=119 Participants
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=122 Participants
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Rate of Inpatient Hospitalization Days for a VOC Through Week 48
|
4.96 Hospitalization days per 48 weeks
Interval 3.05 to 8.07
|
5.37 Hospitalization days per 48 weeks
Interval 3.34 to 8.62
|
SECONDARY outcome
Timeframe: Day 1 up to Week 60 (12 week of follow-up post Week 48)Population: Safety population included randomized participants who received treatment with study drug.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE was defined as an AE with an onset after the initiation of dosing for the first dose of study drug. A serious adverse events (SAE) or serious suspected adverse reaction is an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization and congenital anomaly/birth defect. AEs included both serious and all non-SAEs.
Outcome measures
| Measure |
Inclacumab
n=118 Participants
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=121 Participants
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
87 Participants
Interval 3.05 to 8.07
|
97 Participants
Interval 3.34 to 8.62
|
Adverse Events
Inclacumab
Serious events: 23 serious events
Other events: 83 other events
Deaths: 3 deaths
Placebo
Serious events: 27 serious events
Other events: 90 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Inclacumab
n=118 participants at risk
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=121 participants at risk
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
6.6%
8/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Pyrexia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Malaria
|
4.2%
5/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
5.8%
7/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Pneumonia
|
4.2%
5/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
4.1%
5/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Bacterial infection
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Atypical pneumonia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
COVID-19
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Catheter site infection
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Septic shock
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Migraine
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Sciatica
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
Other adverse events
| Measure |
Inclacumab
n=118 participants at risk
Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
Placebo
n=121 participants at risk
Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
17.8%
21/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
17.4%
21/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
5/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
7.4%
9/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
4/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Cardiac disorders
Tachycardia
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Cardiac disorders
Cor pulmonale acute
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Eye disorders
Conjunctivitis allergic
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Eye disorders
Pterygium
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Eye disorders
Vision blurred
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Eye disorders
Photophobia
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Eye disorders
Retinopathy sickle cell
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
7/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
5/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Peptic ulcer
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Pyrexia
|
5.9%
7/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
3.3%
4/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Pain
|
5.1%
6/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
4.1%
5/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Non-cardiac chest pain
|
3.4%
4/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Fatigue
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Asthenia
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Chest pain
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Chest discomfort
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Gait disturbance
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Influenza like illness
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Malaise
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Oedema peripheral
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Injury associated with device
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Sluggishness
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
General disorders
Swelling
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Hepatobiliary disorders
Cholestasis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Immune system disorders
Seasonal allergy
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Malaria
|
15.3%
18/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
19.8%
24/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
9/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.6%
9/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
9.9%
12/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
COVID-19
|
3.4%
4/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
4/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
3.3%
4/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Influenza
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Pneumonia
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Respiratory tract infection
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Bacteraemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Cellulitis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Cystitis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Fungal infection
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Hordeolum
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Otitis media acute
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Pharyngitis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Sepsis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Sinusitis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Tonsillitis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
5.8%
7/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Vulvovaginitis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
6.6%
8/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Injury, poisoning and procedural complications
Vascular access site pruritus
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
C-reactive protein increased
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Fibrin D dimer increased
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Platelet count decreased
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Blood bilirubin increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Blood creatinine increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Blood fibrinogen decreased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Blood glucose increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Blood potassium increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
C-reactive protein
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Coagulation test abnormal
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Neutrophil count abnormal
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Platelet count increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Protein total decreased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Prothrombin time shortened
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Reticulocyte count increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Reticulocyte percentage increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Serum ferritin increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Weight decreased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
White blood cell count increased
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Blood iron decreased
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.7%
15/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
9.9%
12/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
10/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
11.6%
14/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
7/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
4.1%
5/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
4/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Vascular disorders
Hyperaemia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Headache
|
13.6%
16/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
17.4%
21/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Migraine
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Ageusia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Amnesia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Amputation stump pain
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Dizziness
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Psychogenic seizure
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Syncope
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Psychiatric disorders
Anxiety
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Psychiatric disorders
Depression
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Psychiatric disorders
Insomnia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Renal and urinary disorders
Nephropathy
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Reproductive system and breast disorders
Priapism
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
1.7%
2/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
2.5%
3/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
5.0%
6/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.4%
4/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
2/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Vascular disorders
Hypotension
|
2.5%
3/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Vascular disorders
Flushing
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Vascular disorders
Haematoma
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Vascular disorders
Phlebitis
|
0.85%
1/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.00%
0/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/118 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
0.83%
1/121 • Day 1 up to Week 60 (12 week of follow-up post Week 48)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER