Trial Outcomes & Findings for Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer (NCT NCT00679783)
NCT ID: NCT00679783
Last Updated: 2023-07-12
Results Overview
Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.
Results posted on
2023-07-12
Participant Flow
The first patient was enrolled on July 8, 2008 and efficacy and safety data were collected up to the data cut-off of March 26, 2010. Patients were enrolled at 6 centres in Canada. Of the 112 patients who gave informed consent 21 patients failed eligibility criteria or withdrew their consent and were not allocated to treatment.
The study enrolled both known BRCA mutation carriers and patients with unknown BRCA status. Those with unknown status at entry had to provide a DNA sample for BRCA. One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis. Study data are summarised by confirmed mutation status.
Participant milestones
| Measure |
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
13
|
3
|
45
|
5
|
5
|
16
|
|
Overall Study
COMPLETED
|
2
|
10
|
2
|
25
|
4
|
5
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
20
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
BRCA Positive Non-serous Ovarian
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Not Captured
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
|
Overall Study
Ongoing at data cut-off
|
2
|
2
|
0
|
9
|
1
|
0
|
0
|
Baseline Characteristics
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
Baseline characteristics by cohort
| Measure |
BRCA Positive Non-serous Ovarian
n=4 Participants
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=13 Participants
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
n=3 Participants
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=44 Participants
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
n=5 Participants
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
n=5 Participants
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
n=16 Participants
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60 Year
STANDARD_DEVIATION 18.7 • n=5 Participants
|
53.7 Year
STANDARD_DEVIATION 7.3 • n=7 Participants
|
60.3 Year
STANDARD_DEVIATION 12.9 • n=5 Participants
|
61 Year
STANDARD_DEVIATION 9.5 • n=4 Participants
|
49.4 Year
STANDARD_DEVIATION 20.5 • n=21 Participants
|
44.8 Year
STANDARD_DEVIATION 15.5 • n=10 Participants
|
48.8 Year
STANDARD_DEVIATION 5.5 • n=115 Participants
|
52.9 Year
STANDARD_DEVIATION 13 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
90 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
Outcome measures
| Measure |
BRCA Positive Non-serous Ovarian
n=4 Participants
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=13 Participants
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
n=3 Participants
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=43 Participants
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
n=4 Participants
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
n=4 Participants
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
n=15 Participants
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines
|
75 Percentage of participants
Interval 30.06 to 95.44
|
30.77 Percentage of participants
Interval 12.68 to 57.63
|
0 Percentage of participants
Interval 0.0 to 56.15
|
25.58 Percentage of participants
Interval 14.93 to 40.24
|
0 Percentage of participants
Interval 0.0 to 48.99
|
0 Percentage of participants
Interval 0.0 to 48.99
|
0 Percentage of participants
Interval 0.0 to 20.39
|
SECONDARY outcome
Timeframe: 16 WeeksPercentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)
Outcome measures
| Measure |
BRCA Positive Non-serous Ovarian
n=4 Participants
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=13 Participants
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
n=3 Participants
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=44 Participants
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
n=5 Participants
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
n=5 Participants
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
n=16 Participants
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
75 Percentage of participants
Interval 30.06 to 95.44
|
53.85 Percentage of participants
Interval 29.14 to 76.79
|
0 Percentage of participants
Interval 0.0 to 56.15
|
47.73 Percentage of participants
Interval 33.75 to 62.06
|
60 Percentage of participants
Interval 23.07 to 88.24
|
20 Percentage of participants
Interval 3.62 to 62.45
|
0 Percentage of participants
Interval 0.0 to 19.36
|
SECONDARY outcome
Timeframe: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.
Outcome measures
| Measure |
BRCA Positive Non-serous Ovarian
n=3 Participants
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=4 Participants
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=11 Participants
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response
|
277 Days
Interval 261.0 to 504.0
|
113 Days
Interval 109.0 to 446.0
|
—
|
384 Days
Interval 105.0 to 396.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
Outcome measures
| Measure |
BRCA Positive Non-serous Ovarian
n=4 Participants
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=13 Participants
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
n=2 Participants
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=38 Participants
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
n=4 Participants
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
n=4 Participants
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
n=14 Participants
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
Best Percentage Change From Baseline in Tumour Size
|
-44.5 Percentage
Interval -64.0 to 4.0
|
-21.6 Percentage
Interval -100.0 to 16.0
|
33.6 Percentage
Interval 14.0 to 53.0
|
-14.1 Percentage
Interval -95.0 to 83.0
|
-35.3 Percentage
Interval -48.0 to 10.0
|
-36.4 Percentage
Interval -50.0 to 11.0
|
21.3 Percentage
Interval -3.0 to 50.0
|
SECONDARY outcome
Timeframe: 24 weeksA response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.
Outcome measures
| Measure |
BRCA Positive Non-serous Ovarian
n=4 Participants
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=12 Participants
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
n=3 Participants
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=35 Participants
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
CA-125 Levels (Ovarian Cancer Patients Only)
|
75 Percentage of participants
Interval 30.06 to 95.44
|
33.33 Percentage of participants
Interval 13.81 to 60.94
|
0 Percentage of participants
Interval 0.0 to 56.15
|
28.57 Percentage of participants
Interval 16.33 to 45.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.
Outcome measures
| Measure |
BRCA Positive Non-serous Ovarian
n=4 Participants
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=13 Participants
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
n=3 Participants
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=44 Participants
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
n=5 Participants
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
n=5 Participants
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
n=16 Participants
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
346.5 Days
Interval 51.0 to 553.0
|
219 Days
Interval 1.0 to 503.0
|
79.5 Days
Interval 1.0 to 109.0
|
192 Days
Interval 1.0 to 559.0
|
165 Days
Interval 53.0 to 168.0
|
106 Days
Interval 37.0 to 277.0
|
54 Days
Interval 1.0 to 111.0
|
Adverse Events
BRCA Positive Non-serous Ovarian
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BRCA Positive Serous Ovarian
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
BRCA Negative Non-serous Ovarian
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BRCA Negative Serous Ovarian
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
BRCA Positive Non-triple Negative Breast
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BRCA Positive Triple Negative Breast
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
BRCA Negative Triple Negative Breast
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BRCA Positive Non-serous Ovarian
n=4 participants at risk
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=13 participants at risk
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
n=3 participants at risk
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=44 participants at risk
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
n=5 participants at risk
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
n=5 participants at risk
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
n=16 participants at risk
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Pleural Infection
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Haemoglobin Decreased
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Surgical and medical procedures
Hernia Repair
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
Other adverse events
| Measure |
BRCA Positive Non-serous Ovarian
n=4 participants at risk
Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
|
BRCA Positive Serous Ovarian
n=13 participants at risk
Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
|
BRCA Negative Non-serous Ovarian
n=3 participants at risk
Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Negative Serous Ovarian
n=44 participants at risk
Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
|
BRCA Positive Non-triple Negative Breast
n=5 participants at risk
Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
|
BRCA Positive Triple Negative Breast
n=5 participants at risk
Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don't have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don't work for TNBC)
|
BRCA Negative Triple Negative Breast
n=16 participants at risk
Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Feeling Hot
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.8%
3/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
12.5%
2/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Eye disorders
Visual Impairment
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
69.2%
9/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
66.7%
2/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
63.6%
28/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
60.0%
3/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
100.0%
5/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
50.0%
8/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
30.8%
4/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
40.9%
18/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
40.0%
2/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
60.0%
3/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
25.0%
4/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Abdominal Distension
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
23.1%
3/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
25.0%
11/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
25.0%
11/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
40.0%
2/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
25.0%
11/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
13.6%
6/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
11.4%
5/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
38.5%
5/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
11.4%
5/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
40.0%
2/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
30.8%
4/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
11.4%
5/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.8%
3/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Oesophageal Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Oral Discomfort
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Fatigue
|
100.0%
4/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
92.3%
12/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
63.6%
28/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
60.0%
3/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
60.0%
3/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
43.8%
7/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Oedema Peripheral
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
23.1%
3/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
18.2%
8/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
12.5%
2/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Chills
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Asthenia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Axillary Pain
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Face Oedema
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Influenza Like Illness
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Injection Site Reaction
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Localised Oedema
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Mucosal Inflammation
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Pyrexia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Secretion Discharge
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
General disorders
Thirst
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Hepatobiliary disorders
Hepatic Haemorrhage
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.9%
7/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Breast Cellulitis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Candidiasis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Infection
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Oral Infection
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Sepsis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Skin Infection
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Viral Infection
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Infections and infestations
Vulvovaginitis Streptococcal
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.8%
3/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
9.1%
4/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Alanine Aminotransferase Increased
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Aspartate Aminotransferase Increased
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Blood Alkaline Phosphatase Increased
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Blood Glucose Increased
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Blood Iron Decreased
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Cardiac Murmur
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Electrocardiogram Qt Prolonged
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Gamma-Glutamyltransferase Increased
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Injury, poisoning and procedural complications
Haemoglobin Decreased
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
53.8%
7/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
29.5%
13/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
40.0%
2/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
25.0%
4/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
13.6%
6/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
12.5%
2/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
9.1%
4/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
25.0%
4/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
30.8%
4/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
18.8%
3/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.8%
3/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.8%
3/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
12.5%
2/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
38.5%
5/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.5%
9/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
40.0%
2/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
40.0%
2/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Headache
|
75.0%
3/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.9%
7/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
60.0%
3/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
12.5%
2/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
46.2%
6/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
11.4%
5/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
12.5%
2/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Dysarthria
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Memory Impairment
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Parosmia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Nervous system disorders
Syncope
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.9%
7/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Psychiatric disorders
Depression
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Psychiatric disorders
Mood Altered
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Reproductive system and breast disorders
Breast Pain
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Reproductive system and breast disorders
Genital Rash
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Reproductive system and breast disorders
Oedema Genital
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Reproductive system and breast disorders
Pelvic Discomfort
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Reproductive system and breast disorders
Pelvic Pain
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
38.5%
5/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
11.4%
5/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
11.4%
5/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
40.0%
2/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
18.8%
3/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
15.4%
2/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
4.5%
2/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
23.1%
3/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
13.6%
6/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
9.1%
4/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
18.8%
3/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
2.3%
1/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.0%
1/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Skin Nodule
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
7.7%
1/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
33.3%
1/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
20.0%
1/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/13
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/3
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/44
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
0.00%
0/5
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
6.2%
1/16
One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60