Trial Outcomes & Findings for GBT021601-022: A Study of GBT021601 in Participants With Sickle Cell Disease (SCD) (NCT NCT05632354)
NCT ID: NCT05632354
Last Updated: 2026-03-19
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. Serious adverse events (SAEs) were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. TEAEs are events between first dose of study drug and up to 56 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of any AE to treatment was based on investigator decision. AEs included both SAEs and all non-serious AEs.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
47 participants
Primary outcome timeframe
From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Results posted on
2026-03-19
Participant Flow
A total of 47 participants from only Part A of the parent study C5351004 \[NCT05431088\] were enrolled in the current study C5351005 \[NCT05632354\]. Study was terminated based on Sponsor's decision. There were no participants enrolled in 'Participants With Delayed Start: Osivelotor 200 mg' group.
Participant milestones
| Measure |
Participants Without Delayed Start: Osivelotor 100 Milligram (mg)
Participants with sickle cell disease (SCD) who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 200 mg
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
1
|
5
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
17
|
1
|
5
|
6
|
Reasons for withdrawal
| Measure |
Participants Without Delayed Start: Osivelotor 100 Milligram (mg)
Participants with sickle cell disease (SCD) who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 200 mg
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
12
|
16
|
1
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Non-compliance with study treatment
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
GBT021601-022: A Study of GBT021601 in Participants With Sickle Cell Disease (SCD)
Baseline characteristics by cohort
| Measure |
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.4 Years
STANDARD_DEVIATION 13.75 • n=110 Participants
|
27.2 Years
STANDARD_DEVIATION 10.19 • n=114 Participants
|
27.0 Years
STANDARD_DEVIATION NA • n=224 Participants
|
26.4 Years
STANDARD_DEVIATION 11.70 • n=104 Participants
|
27.8 Years
STANDARD_DEVIATION 14.41 • n=2 Participants
|
29.6 Years
STANDARD_DEVIATION 12.25 • n=2 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=110 Participants
|
11 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
3 Participants
n=104 Participants
|
4 Participants
n=2 Participants
|
28 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=110 Participants
|
6 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
2 Participants
n=104 Participants
|
2 Participants
n=2 Participants
|
19 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=110 Participants
|
17 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
5 Participants
n=104 Participants
|
6 Participants
n=2 Participants
|
47 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Race · African
|
10 Participants
n=110 Participants
|
12 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
5 Participants
n=104 Participants
|
6 Participants
n=2 Participants
|
33 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
8 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
14 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. Serious adverse events (SAEs) were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. TEAEs are events between first dose of study drug and up to 56 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of any AE to treatment was based on investigator decision. AEs included both SAEs and all non-serious AEs.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment emergent SAEs
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment-Related Treatment-Emergent SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment Emergent Non-Serious AEs
|
1 Participants
|
14 Participants
|
13 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE
|
1 Participants
|
14 Participants
|
13 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment related TEAE
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here, 'Overall Number of Participants Analyzed' (N) signifies participants evaluable for this outcome measure.
Change from baseline in hematocrit at week 12 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=15 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=12 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematocrit at Week 12
|
-1.9 Percent
Standard Deviation NA
Standard deviation was not calculated as there was only one participant.
|
-0.3 Percent
Standard Deviation 5.88
|
-3.9 Percent
Standard Deviation 7.53
|
7.0 Percent
Standard Deviation 5.74
|
10.0 Percent
Standard Deviation 2.37
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Change from baseline in hematocrit at week 48 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=12 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=12 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=4 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematocrit at Week 48
|
-9.9 Percent
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-2.4 Percent
Standard Deviation 7.71
|
-5.5 Percent
Standard Deviation 8.61
|
4.5 Percent
Standard Deviation 4.12
|
5.5 Percent
Standard Deviation 5.00
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Change from baseline in leukocytes at week 12 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=15 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=12 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Leukocytes at Week 12
|
0.9 10^9 cells per liter (10^9 cells/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
1.7 10^9 cells per liter (10^9 cells/L)
Standard Deviation 2.68
|
0.8 10^9 cells per liter (10^9 cells/L)
Standard Deviation 1.87
|
0.3 10^9 cells per liter (10^9 cells/L)
Standard Deviation 1.92
|
-1.8 10^9 cells per liter (10^9 cells/L)
Standard Deviation 2.28
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Change from baseline in leukocytes at week 48 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=12 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=12 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=4 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Leukocytes Week 48
|
2.4 10^9 cells/L
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
1.7 10^9 cells/L
Standard Deviation 3.35
|
2.8 10^9 cells/L
Standard Deviation 3.22
|
1.0 10^9 cells/L
Standard Deviation 1.82
|
-0.4 10^9 cells/L
Standard Deviation 1.74
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
Change from baseline in SBP at week 12 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Supine Blood Pressure (SBP) at Week 12
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-3.4 Millimeters of mercury (mmHg)
Standard Deviation 7.83
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 10.72
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 4.42
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 5.10
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Change from baseline in SBP at week 48 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=13 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=16 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=4 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in SBP at Week 48
|
0.0 mmHg
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-2.5 mmHg
Standard Deviation 12.34
|
-2.3 mmHg
Standard Deviation 11.48
|
-0.8 mmHg
Standard Deviation 11.50
|
-0.4 mmHg
Standard Deviation 9.43
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
Change from baseline in DBP at week 12 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
|
-2.0 mmHg
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-3.9 mmHg
Standard Deviation 7.91
|
-0.8 mmHg
Standard Deviation 7.28
|
1.0 mmHg
Standard Deviation 5.96
|
-1.7 mmHg
Standard Deviation 14.04
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Change from baseline in DBP at week 48 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=13 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=16 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=4 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in DBP at Week 48
|
1.0 mmHg
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-4.4 mmHg
Standard Deviation 8.99
|
-0.4 mmHg
Standard Deviation 7.62
|
4.3 mmHg
Standard Deviation 13.55
|
-1.5 mmHg
Standard Deviation 16.77
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to last dose of study drug (approximately up to 680 days)Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. The annualized rate and corresponding 95% CI for each dose arm and overall (100 mg + 150 mg) was reported in this outcome measure as pre-specified in statistical analysis plan
A VOC was defined as an acute episode of pain that had no medically determined cause other than a vaso-occlusive event, and resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. Annualized rate of VOC was reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=46 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=23 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=23 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Annualized Rate of Vaso-Occlusive Crisis (VOC)
|
1.07 VOC events per year
Interval 0.67 to 1.7
|
1.01 VOC events per year
Interval 0.5 to 2.04
|
1.11 VOC events per year
Interval 0.59 to 2.09
|
NA VOC events per year
Number and 95%CI could not be estimated since there was only one evaluable participant.
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
SCD is an inherited disorder caused by a point mutation in the beta globin gene which leads to formation of sickle hemoglobin (HbS). SAEs were defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Number of Participants With Sickle Cell Disease (SCD) Related Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, and 60Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here 'Number Analyzed' (n) signifies participants evaluable at specified timepoints.
Change from baseline in hemoglobin at weeks 12, 24, 36, 48 and 60 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin at Weeks 12, 24, 36, 48, and 60
Change at week 24
|
0.0 Grams per deciliter (g/dL)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
0.0 Grams per deciliter (g/dL)
Standard Deviation 1.64
|
-0.9 Grams per deciliter (g/dL)
Standard Deviation 1.84
|
2.0 Grams per deciliter (g/dL)
Standard Deviation 1.70
|
2.4 Grams per deciliter (g/dL)
Standard Deviation 1.97
|
|
Change From Baseline in Hemoglobin at Weeks 12, 24, 36, 48, and 60
Change at week 36
|
1.0 Grams per deciliter (g/dL)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-0.3 Grams per deciliter (g/dL)
Standard Deviation 1.49
|
-1.2 Grams per deciliter (g/dL)
Standard Deviation 2.46
|
2.3 Grams per deciliter (g/dL)
Standard Deviation 1.35
|
2.1 Grams per deciliter (g/dL)
Standard Deviation 2.69
|
|
Change From Baseline in Hemoglobin at Weeks 12, 24, 36, 48, and 60
Change at week 12
|
-0.1 Grams per deciliter (g/dL)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
0.2 Grams per deciliter (g/dL)
Standard Deviation 1.68
|
-0.6 Grams per deciliter (g/dL)
Standard Deviation 1.36
|
2.0 Grams per deciliter (g/dL)
Standard Deviation 1.55
|
3.4 Grams per deciliter (g/dL)
Standard Deviation 0.88
|
|
Change From Baseline in Hemoglobin at Weeks 12, 24, 36, 48, and 60
Change at week 48
|
-3.2 Grams per deciliter (g/dL)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-0.8 Grams per deciliter (g/dL)
Standard Deviation 2.65
|
-1.4 Grams per deciliter (g/dL)
Standard Deviation 1.97
|
1.1 Grams per deciliter (g/dL)
Standard Deviation 1.10
|
1.6 Grams per deciliter (g/dL)
Standard Deviation 1.87
|
|
Change From Baseline in Hemoglobin at Weeks 12, 24, 36, 48, and 60
Change at week 60
|
—
|
-1.7 Grams per deciliter (g/dL)
Standard Deviation 1.67
|
-2.5 Grams per deciliter (g/dL)
Standard Deviation 1.93
|
0.4 Grams per deciliter (g/dL)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
0.3 Grams per deciliter (g/dL)
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, and 60Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here 'Number Analyzed' signifies participants evaluable at specified timepoints.
Change from baseline in reticulocytes at weeks 12, 24, 36, 48 and 60 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Reticulocytes at Weeks 12, 24, 36, 48, and 60
Change at week 36
|
-64.0 10^9 cells/L
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
39.6 10^9 cells/L
Standard Deviation 99.22
|
82.9 10^9 cells/L
Standard Deviation 115.86
|
93.0 10^9 cells/L
Standard Deviation 161.13
|
25.7 10^9 cells/L
Standard Deviation 96.34
|
|
Change From Baseline in Reticulocytes at Weeks 12, 24, 36, 48, and 60
Change at week 60
|
—
|
-9.8 10^9 cells/L
Standard Deviation 136.44
|
-8.1 10^9 cells/L
Standard Deviation 109.27
|
-41.4 10^9 cells/L
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-21.4 10^9 cells/L
Standard Deviation 175.33
|
|
Change From Baseline in Reticulocytes at Weeks 12, 24, 36, 48, and 60
Change at week 12
|
68.4 10^9 cells/L
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
16.4 10^9 cells/L
Standard Deviation 106.94
|
-1.2 10^9 cells/L
Standard Deviation 95.34
|
10.5 10^9 cells/L
Standard Deviation 90.08
|
-24.7 10^9 cells/L
Standard Deviation 149.35
|
|
Change From Baseline in Reticulocytes at Weeks 12, 24, 36, 48, and 60
Change at week 24
|
-11.3 10^9 cells/L
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-22.5 10^9 cells/L
Standard Deviation 132.67
|
26.7 10^9 cells/L
Standard Deviation 102.47
|
-77.1 10^9 cells/L
Standard Deviation 75.00
|
-52.9 10^9 cells/L
Standard Deviation 52.41
|
|
Change From Baseline in Reticulocytes at Weeks 12, 24, 36, 48, and 60
Change at week 48
|
326.0 10^9 cells/L
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
8.2 10^9 cells/L
Standard Deviation 105.75
|
34.4 10^9 cells/L
Standard Deviation 71.33
|
8.9 10^9 cells/L
Standard Deviation 138.88
|
-45.4 10^9 cells/L
Standard Deviation 87.01
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, and 60Population: Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study. Here 'Number Analyzed' signifies participants evaluable at specified timepoints.
Change from baseline in LDH at weeks 12, 24, 36, 48 and 60 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
n=1 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 12, 24, 36, 48, and 60
Change at week 36
|
30.0 International units per liter (IU/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
54.1 International units per liter (IU/L)
Standard Deviation 80.90
|
22.6 International units per liter (IU/L)
Standard Deviation 127.73
|
-40.0 International units per liter (IU/L)
Standard Deviation 177.92
|
-67.7 International units per liter (IU/L)
Standard Deviation 148.38
|
|
Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 12, 24, 36, 48, and 60
Change at week 48
|
525.0 International units per liter (IU/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
172.4 International units per liter (IU/L)
Standard Deviation 358.05
|
78.0 International units per liter (IU/L)
Standard Deviation 199.23
|
-94.8 International units per liter (IU/L)
Standard Deviation 124.77
|
-18.4 International units per liter (IU/L)
Standard Deviation 99.78
|
|
Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 12, 24, 36, 48, and 60
Change at week 12
|
171.0 International units per liter (IU/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-40.1 International units per liter (IU/L)
Standard Deviation 176.92
|
-20.0 International units per liter (IU/L)
Standard Deviation 104.40
|
168.8 International units per liter (IU/L)
Standard Deviation 703.08
|
107.8 International units per liter (IU/L)
Standard Deviation 471.09
|
|
Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 12, 24, 36, 48, and 60
Change at week 24
|
71.0 International units per liter (IU/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
35.7 International units per liter (IU/L)
Standard Deviation 103.08
|
9.9 International units per liter (IU/L)
Standard Deviation 133.71
|
-96.8 International units per liter (IU/L)
Standard Deviation 144.55
|
-78.5 International units per liter (IU/L)
Standard Deviation 177.58
|
|
Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 12, 24, 36, 48, and 60
Change at week 60
|
—
|
207.2 International units per liter (IU/L)
Standard Deviation 298.85
|
70.4 International units per liter (IU/L)
Standard Deviation 164.24
|
-41.0 International units per liter (IU/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
43.0 International units per liter (IU/L)
Standard Deviation 72.12
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, and 60Population: Safety analysis set. Participants were analyzed according to assigned daily maintenance dose on study day 1 in OLE study. Here, 'N'= participants evaluable for this outcome measure and 'n'=participants evaluable at specified timepoints. 'N'=0 for 'Participants without delayed start: Osivelotor 200 mg' group since data for the participant was missing at baseline, so change from baseline could not be calculated for unconjugated bilirubin parameter.
Change from baseline in unconjugated bilirubin at weeks 12, 24, 36, 48 and 60 were reported in this outcome measure.
Outcome measures
| Measure |
Participants Without Delayed Start: Osivelotor 200 mg
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 100 mg
n=18 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 Participants
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Change From Baseline in Unconjugated Bilirubin at Weeks 12, 24, 36, 48, and 60
Change at week 12
|
—
|
0.6 Micromoles per liter (mcmol/L)
Standard Deviation 6.88
|
0.3 Micromoles per liter (mcmol/L)
Standard Deviation 9.52
|
-21.9 Micromoles per liter (mcmol/L)
Standard Deviation 16.21
|
-3.8 Micromoles per liter (mcmol/L)
Standard Deviation 37.57
|
|
Change From Baseline in Unconjugated Bilirubin at Weeks 12, 24, 36, 48, and 60
Change at week 24
|
—
|
-2.8 Micromoles per liter (mcmol/L)
Standard Deviation 4.55
|
-4.9 Micromoles per liter (mcmol/L)
Standard Deviation 13.66
|
-19.3 Micromoles per liter (mcmol/L)
Standard Deviation 20.20
|
-3.4 Micromoles per liter (mcmol/L)
Standard Deviation 12.10
|
|
Change From Baseline in Unconjugated Bilirubin at Weeks 12, 24, 36, 48, and 60
Change at week 36
|
—
|
-2.8 Micromoles per liter (mcmol/L)
Standard Deviation 19.47
|
1.6 Micromoles per liter (mcmol/L)
Standard Deviation 10.35
|
-14.9 Micromoles per liter (mcmol/L)
Standard Deviation 32.98
|
2.1 Micromoles per liter (mcmol/L)
Standard Deviation 23.87
|
|
Change From Baseline in Unconjugated Bilirubin at Weeks 12, 24, 36, 48, and 60
Change at week 48
|
—
|
7.1 Micromoles per liter (mcmol/L)
Standard Deviation 31.00
|
8.5 Micromoles per liter (mcmol/L)
Standard Deviation 11.12
|
-19.5 Micromoles per liter (mcmol/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-12.2 Micromoles per liter (mcmol/L)
Standard Deviation 21.88
|
|
Change From Baseline in Unconjugated Bilirubin at Weeks 12, 24, 36, 48, and 60
Change at week 60
|
—
|
0.5 Micromoles per liter (mcmol/L)
Standard Deviation 8.63
|
8.2 Micromoles per liter (mcmol/L)
Standard Deviation 21.07
|
-0.5 Micromoles per liter (mcmol/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
-13.0 Micromoles per liter (mcmol/L)
Standard Deviation NA
Standard deviation was not calculated as there was only one evaluable participant.
|
Adverse Events
Participants Without Delayed Start: Osivelotor 100 mg
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Participants Without Delayed Start: Osivelotor 150 mg
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Participants Without Delayed Start: Osivelotor 200 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants With Delayed Start: Osivelotor 100 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Participants With Delayed Start: Osivelotor 150 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants Without Delayed Start: Osivelotor 100 mg
n=18 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 200 mg
n=1 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Blood and lymphatic system disorders
Haemolysis
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
100.0%
1/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Nervous system disorders
Cerebral infarction
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
Other adverse events
| Measure |
Participants Without Delayed Start: Osivelotor 100 mg
n=18 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 150 mg
n=17 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants Without Delayed Start: Osivelotor 200 mg
n=1 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received osivelotor 200 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants without any delay in start of treatment were included.
|
Participants With Delayed Start: Osivelotor 100 mg
n=5 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received 100 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
Participants With Delayed Start: Osivelotor 150 mg
n=6 participants at risk
Participants with SCD who participated in a previous osivelotor clinical study and received 150 mg tablet orally and completed the end of treatment visit in this study for up to 680 days. Participants with delayed start are those with a gap in dosing greater than 42 consecutive days from completing the originating study (C5351005 Date of First Dose - C5351004 End of Treatment Date + 1 greater than 42).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
100.0%
1/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Eye disorders
Dry eye
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
11.8%
2/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Gastrointestinal disorders
Peptic ulcer
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Gastrointestinal disorders
Stress ulcer
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Gastrointestinal disorders
Dental caries
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
General disorders
Pain
|
11.1%
2/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
17.6%
3/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
50.0%
3/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
General disorders
Oedema
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
General disorders
Chest pain
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
100.0%
1/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
General disorders
Peripheral swelling
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
100.0%
1/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Hepatobiliary disorders
Jaundice
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Malaria
|
22.2%
4/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
41.2%
7/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
60.0%
3/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
50.0%
3/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
29.4%
5/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
60.0%
3/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
50.0%
3/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
11.8%
2/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
11.8%
2/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
2/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Bronchitis
|
11.1%
2/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
COVID-19
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Osteomyelitis
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
11.8%
2/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Pharyngotonsillitis
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
11.8%
2/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Tetanus
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Investigations
Platelet count increased
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
11.8%
2/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
100.0%
1/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
100.0%
1/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Nervous system disorders
Burning sensation
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Nervous system disorders
Sciatica
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
16.7%
3/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
40.0%
2/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
100.0%
1/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
5.9%
1/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Vascular disorders
Pallor
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
16.7%
1/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/18 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/17 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/1 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
20.0%
1/5 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
0.00%
0/6 • From first dose of study drug up to 56 days after last dose of study drug (approximately up to 736 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all enrolled participants who had received at least one dose of study drug in this OLE study. Participants were analyzed according to the assigned daily maintenance dose on study day 1 in the OLE study.
|
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