Trial Outcomes & Findings for Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) (NCT NCT00441090)
NCT ID: NCT00441090
Last Updated: 2018-03-07
Results Overview
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Day 28. The RR was defined as the percentage of participants with a Day 1 platelet count of less than 30,000/milliliter (mL) who reached a platelet count of greater than or equal to 50,000/mL on Day 28 of study medication, together with the percentage of participants using steroids who had a Day 1 platelet count greater than or equal to 30,000/mL but less than 50,000/mL who reached a platelet count of greater than or equal to 20,000/mL higher than their Day 1 platelet count on Day 28 of study medication. The RR was summarized by treatment group using the method of last observation carried forward (LOCF).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Day-4 to Day 1, Baseline, Day 28
Results posted on
2018-03-07
Participant Flow
Participant milestones
| Measure |
2.5 mg Avatrombopag
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
14
|
15
|
5
|
|
Overall Study
COMPLETED
|
13
|
14
|
12
|
13
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
2.5 mg Avatrombopag
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Platelet increase;more than 500,000 mm^3
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Baseline characteristics by cohort
| Measure |
2.5 mg Avatrombopag
n=15 Participants
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 Participants
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 Participants
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 Participants
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 Participants
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.9 Years
STANDARD_DEVIATION 17.84 • n=5 Participants
|
55.6 Years
STANDARD_DEVIATION 18.03 • n=7 Participants
|
57.5 Years
STANDARD_DEVIATION 17.88 • n=5 Participants
|
47.9 Years
STANDARD_DEVIATION 16.54 • n=4 Participants
|
39.6 Years
STANDARD_DEVIATION 20.63 • n=21 Participants
|
52.3 Years
STANDARD_DEVIATION 17.81 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day-4 to Day 1, Baseline, Day 28Population: Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Day 28. The RR was defined as the percentage of participants with a Day 1 platelet count of less than 30,000/milliliter (mL) who reached a platelet count of greater than or equal to 50,000/mL on Day 28 of study medication, together with the percentage of participants using steroids who had a Day 1 platelet count greater than or equal to 30,000/mL but less than 50,000/mL who reached a platelet count of greater than or equal to 20,000/mL higher than their Day 1 platelet count on Day 28 of study medication. The RR was summarized by treatment group using the method of last observation carried forward (LOCF).
Outcome measures
| Measure |
2.5 mg Avatrombopag
n=15 Participants
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 Participants
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 Participants
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 Participants
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 Participants
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Responder Rate (RR) to Avatrombopag on Day 28
|
13.3 Percentage of participants
|
53.3 Percentage of participants
|
50.0 Percentage of participants
|
80.0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, Day 28Population: Full Analysis population, LOCF
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28. The unit of measure was "K/mm\^3", where "K = platelets x 1000 = platelets x 10\^3" and "mm\^3 = cubic milliliter= microliter".
Outcome measures
| Measure |
2.5 mg Avatrombopag
n=15 Participants
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 Participants
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 Participants
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 Participants
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 Participants
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Change in Platelet Count From Baseline
Day 7
|
13.6 platelets x 10^3/mm^3
Standard Deviation 22.37
|
46.7 platelets x 10^3/mm^3
Standard Deviation 55.22
|
68.3 platelets x 10^3/mm^3
Standard Deviation 81.23
|
168.8 platelets x 10^3/mm^3
Standard Deviation 114.59
|
5.0 platelets x 10^3/mm^3
Standard Deviation 9.54
|
|
Change in Platelet Count From Baseline
Day 14
|
12.5 platelets x 10^3/mm^3
Standard Deviation 22.64
|
57.5 platelets x 10^3/mm^3
Standard Deviation 74.72
|
103.1 platelets x 10^3/mm^3
Standard Deviation 119.55
|
332.4 platelets x 10^3/mm^3
Standard Deviation 278.96
|
-1.4 platelets x 10^3/mm^3
Standard Deviation 4.16
|
|
Change in Platelet Count From Baseline
Day 21
|
7.5 platelets x 10^3/mm^3
Standard Deviation 18.38
|
47.1 platelets x 10^3/mm^3
Standard Deviation 54.54
|
80.6 platelets x 10^3/mm^3
Standard Deviation 129.98
|
261.3 platelets x 10^3/mm^3
Standard Deviation 278.17
|
8.4 platelets x 10^3/mm^3
Standard Deviation 13.72
|
|
Change in Platelet Count From Baseline
Day 28
|
7.3 platelets x 10^3/mm^3
Standard Deviation 23.74
|
43.7 platelets x 10^3/mm^3
Standard Deviation 50.35
|
81.0 platelets x 10^3/mm^3
Standard Deviation 124.55
|
200.2 platelets x 10^3/mm^3
Standard Deviation 292.36
|
-1.8 platelets x 10^3/mm^3
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Day -4 to Day 1, Baseline, Day 7, Day 14, and Day 21Population: Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, and 21. The RR was summarized by treatment group using the method of LOCF. Day 28 was not included with this data because it was reported as a primary outcome measure.
Outcome measures
| Measure |
2.5 mg Avatrombopag
n=15 Participants
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 Participants
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 Participants
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 Participants
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 Participants
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Responder Rate to Avatrombopag by Visit
Day 7
|
6.7 Percentage of participants
|
66.7 Percentage of participants
|
64.3 Percentage of participants
|
93.3 Percentage of participants
|
0 Percentage of participants
|
|
Responder Rate to Avatrombopag by Visit
Day 14
|
20.0 Percentage of participants
|
60.0 Percentage of participants
|
78.6 Percentage of participants
|
93.3 Percentage of participants
|
0 Percentage of participants
|
|
Responder Rate to Avatrombopag by Visit
Day 21
|
13.3 Percentage of participants
|
60.0 Percentage of participants
|
50.0 Percentage of participants
|
86.7 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28Population: Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.
Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Outcome measures
| Measure |
2.5 mg Avatrombopag
n=15 Participants
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 Participants
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 Participants
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 Participants
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 Participants
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit
Day 7
|
6.7 Percentage of participants
|
66.7 Percentage of participants
|
64.3 Percentage of participants
|
93.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit
Day 14
|
20.0 Percentage of participants
|
60.0 Percentage of participants
|
78.6 Percentage of participants
|
93.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit
Day 21
|
13.3 Percentage of participants
|
60.0 Percentage of participants
|
50.0 Percentage of participants
|
86.7 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit
Day 28
|
13.3 Percentage of participants
|
53.3 Percentage of participants
|
50.0 Percentage of participants
|
80.0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28Population: Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Outcome measures
| Measure |
2.5 mg Avatrombopag
n=15 Participants
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 Participants
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 Participants
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 Participants
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 Participants
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit
Day 7
|
6.7 Percentage of participants
|
20.0 Percentage of participants
|
28.6 Percentage of participants
|
80.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit
Day 14
|
0 Percentage of participants
|
26.7 Percentage of participants
|
42.9 Percentage of participants
|
86.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit
Day 21
|
0 Percentage of participants
|
20.0 Percentage of participants
|
21.4 Percentage of participants
|
73.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit
Day 28
|
6.7 Percentage of participants
|
33.3 Percentage of participants
|
28.6 Percentage of participants
|
53.3 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28Population: Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.
Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.
Outcome measures
| Measure |
2.5 mg Avatrombopag
n=15 Participants
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 Participants
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 Participants
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 Participants
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 Participants
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit
Day 7
|
33.3 Percentage of participants
|
60.0 Percentage of participants
|
78.6 Percentage of participants
|
93.3 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit
Day 14
|
26.7 Percentage of participants
|
60.0 Percentage of participants
|
71.4 Percentage of participants
|
93.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit
Day 21
|
6.7 Percentage of participants
|
60.0 Percentage of participants
|
64.3 Percentage of participants
|
86.7 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit
Day 28
|
13.3 Percentage of participants
|
53.3 Percentage of participants
|
57.1 Percentage of participants
|
86.7 Percentage of participants
|
20.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 7, 14, 21 and 28Population: Given the sparse PK sampling in this study, PK data from outside studies, which includes healthy subjects, were included to assist in PK model development. As a result this data was not reported with these study results.
Given the sparse PK sampling in this study, PK data from outside studies, which includes healthy subjects, were included to assist in PK model development. As a result this data was not reported with these study results.
Outcome measures
Outcome data not reported
Adverse Events
2.5 mg Avatrombopag
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
5.0 mg Avatrombopag
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
10.0 mg Avatrombopag
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
20.0 mg Avatrombopag
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.5 mg Avatrombopag
n=15 participants at risk
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 participants at risk
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 participants at risk
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 participants at risk
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 participants at risk
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Eye disorders
Renal artery occlusion
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Gastric haemorrhagic
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
Other adverse events
| Measure |
2.5 mg Avatrombopag
n=15 participants at risk
2.5 mg tablet taken orally once daily for 28 days
|
5.0 mg Avatrombopag
n=15 participants at risk
5.0 mg tablet taken orally once daily for 28 days
|
10.0 mg Avatrombopag
n=14 participants at risk
10.0 mg tablet taken orally once daily for 28 days
|
20.0 mg Avatrombopag
n=15 participants at risk
20.0 mg tablet taken orally once daily for 28 days
|
Placebo
n=5 participants at risk
3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Ear and labyrinth disorders
Tympanic membrance disorder
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Ear and labyrinth disorders
Auricular swelling
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Eye disorders
Photophobia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
14.3%
2/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Gingival bleeding
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Abdominal upper pain
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Oral mucosal petechiae
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Gastrointestinal disorders
Bowel sounds abnormal
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
General disorders
Fatigue
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
26.7%
4/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
28.6%
4/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
General disorders
Asthenia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
General disorders
Hunger
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
14.3%
2/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Infections and infestations
Bacterial infection
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Infections and infestations
Furnuncle
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Infections and infestations
Horeolum
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Infections and infestations
Nasopharyngtis
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Investigations
Platelet count increased
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
26.7%
4/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Investigations
Blood glucose increased
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
3/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
26.7%
4/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Nervous system disorders
Anxiety
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.7%
4/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
21.4%
3/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
20.0%
1/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
7.1%
1/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Vascular disorders
Vasoconstriction
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
General disorders
Pain
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/14 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from first dose of study drug until last follow-up visit, or 30 days following discontinuation of study drug, whichever occurred later, or approximately 91 days.
Safety population included all participants who received at least one dose of study drug and had at least one safety assessment. Treatment-emergent AEs and SAEs are new events, or worsening of pre-existing events, that occur after the first dose of study drug and were reported in this section.
|
Additional Information
Eisai Medical Services
Eisai Inc.
Phone: 1-888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER