Trial Outcomes & Findings for Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF) (NCT NCT01348490)
NCT ID: NCT01348490
Last Updated: 2020-01-28
Results Overview
Magnetic resonance imaging (MRI) of the upper and lower abdomen and pelvis was performed to assess spleen volumes. Computed tomography (CT) scan was performed if participant was not a candidate for MRI or if MRI was not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2020-01-28
Participant Flow
Participants took part in the study at 27 investigative sites in the United States from 15 June 2011 to 19 December 2018.
A total of 66 participants were enrolled in the study. Fifty-five participants completed 24 weeks of treatment (core treatment period), and 23 participants entered the extension phase.
Participant milestones
| Measure |
Ruxolitinib 5 Milligram (mg)
Doses may not exceed 10 mg bid except in subjects who continue to meet the above dose escalation criteria, and who have, in addition, a PGIC score of minimally worse, much worse or very much worse while receiving 10 mg bid. Such subjects may continue dose escalation to a maximum dose of 15 mg bid.
During the extended treatment phase, doses of ruxolitinib may be increased in 5 mg qd increments up to a dose of 25 mg bid if the subject meets the above dose escalation criteria, or per the investigator's discretion.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Ruxolitinib 5 Milligram (mg)
Doses may not exceed 10 mg bid except in subjects who continue to meet the above dose escalation criteria, and who have, in addition, a PGIC score of minimally worse, much worse or very much worse while receiving 10 mg bid. Such subjects may continue dose escalation to a maximum dose of 15 mg bid.
During the extended treatment phase, doses of ruxolitinib may be increased in 5 mg qd increments up to a dose of 25 mg bid if the subject meets the above dose escalation criteria, or per the investigator's discretion.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Consent withdrawn
|
7
|
|
Overall Study
Disease progression
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Termination of clinical trial by sponsor
|
1
|
|
Overall Study
Other Unspecified
|
8
|
Baseline Characteristics
Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)
Baseline characteristics by cohort
| Measure |
Ruxolitinib 5 mg
n=66 Participants
Doses may not exceed 10 mg bid except in subjects who continue to meet the above dose escalation criteria, and who have, in addition, a PGIC score of minimally worse, much worse or very much worse while receiving 10 mg bid. Such subjects may continue dose escalation to a maximum dose of 15 mg bid.
During the extended treatment phase, doses of ruxolitinib may be increased in 5 mg qd increments up to a dose of 25 mg bid if the subject meets the above dose escalation criteria, or per the investigator's discretion.
|
|---|---|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic or Non-Latino
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat (ITT) population included all participants enrolled and treated in the study.
Magnetic resonance imaging (MRI) of the upper and lower abdomen and pelvis was performed to assess spleen volumes. Computed tomography (CT) scan was performed if participant was not a candidate for MRI or if MRI was not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=16 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=2 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=27 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=6 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Spleen Volume at Week 24 by Final Titrated Dose
|
-11.6 Percentage change from baseline
Standard Deviation 18.68
|
-17.4 Percentage change from baseline
Standard Deviation 0.63
|
-22.4 Percentage change from baseline
Standard Deviation 22.86
|
-13.4 Percentage change from baseline
Standard Deviation 22.29
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: ITT population included all participants enrolled and treated in the study. For the 5 mg AM/ 10 mg PM arm, the t-test was not calculated due to only having a single participant.
Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=17 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=1 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=29 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=6 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Symptom Score (TSS) as Measured by the Modified Myelofibrosis Symptom Assessment Form (MFSAF) V2.0 Diary at Week 24 by Final Titrated Dose
|
-6.35 Percentage change from baseline
Standard Deviation 64.207
|
-39.51 Percentage change from baseline
Standard Deviation NA
Standard deviation was not calculated due to only having a single participant.
|
-47.54 Percentage change from baseline
Standard Deviation 46.886
|
7.95 Percentage change from baseline
Standard Deviation 113.17
|
—
|
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety evaluable population included participants who received at least 1 dose of study drug.
TEAE was defined as adverse events that began or worsened from baseline after the first administration of the study drug. Participants were analyzed based on the number of subjects who received a dose within the dose group. The percentages for each column are calculated using this N. Participants who had more than 1 event in an AE category (eg, treatment-related TEAE) are counted once at each dose level the event occurred.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=15 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=66 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=54 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=44 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
n=9 Participants
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAE)
|
93.3 percentage of participants
|
74.2 percentage of participants
|
61.1 percentage of participants
|
77.3 percentage of participants
|
55.6 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety evaluable population included participants who received at least 1 dose of study drug.
Participants with platelet count between 50 and 100 × 10\^9/L at the screening and/or baseline visit were enrolled in the study. Thrombocytopenia is defined as a condition with low blood platelet count. Grade 4 thrombocytopenia was platelet count \< 25 × 10\^9/L. Participants were analyzed based on the number of subjects who received a dose within the dose group. The percentages for each column are calculated using this N. Participants who had more than 1 event in an AE category (eg, treatment-related TEAE) are counted once at each dose level the event occurred.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=13 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=66 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=53 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=43 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
n=8 Participants
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percentage of Participants With New Onset Grade 4 Thrombocytopenia Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE V4.03)
|
23.1 percentage of participants
|
3.0 percentage of participants
|
5.7 percentage of participants
|
4.7 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety evaluable population included participants who received at least 1 dose of study drug.
Hemorrhages were defined as any lower level terms by MedDRA included in the Standardized MedDRA Query (SMQ) for hemorrhage terms. Participants were analyzed based on the number of subjects who received a dose within the dose group. The percentages for each column are calculated using this N. Participants who had more than 1 event in an AE category (eg, treatment-related TEAE) are counted once at each dose level the event occurred.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=15 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=66 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=54 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=44 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
n=9 Participants
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percentage of Participants With New Onset Grade 2 or Higher Hemorrhage as Assessed by CTCAE V4.03
|
6.7 percentage of participants
|
3.0 percentage of participants
|
1.9 percentage of participants
|
2.3 percentage of participants
|
11.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population included all participants enrolled and treated in the study.
MRI of the upper and lower abdomen and pelvis was performed, to assess spleen volumes. CT scan was performed if participant was not a candidate for MRI, or if MRI was not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=51 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percent Change in Spleen Volume at Week 24 Compared to Baseline
|
-17.8 Percentage
Standard Deviation 21.27
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population included all participants enrolled and treated in the study.
Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms..
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=53 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percent Change in Total Symptom Score as Measured by the Modified MFSAF V2.0 Diary at Week 24 Compared to Baseline
|
-27.90 Percentage change from baseline
Standard Deviation 64.818
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Efficacy evaluable participants included all participants enrolled and treated in the study.
MRI of the upper and lower abdomen and pelvis was performed, to assess spleen volumes. CT scan was performed if participant is not a candidate for MRI, or if MRI is not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=21 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=3 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=33 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=7 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 24 Compared to Baseline
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
24.2 percentage of participants
Interval 11.1 to 42.3
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Efficacy evaluable participants included all participants enrolled and treated in the study.
MRI of the upper and lower abdomen and pelvis was performed, to assess spleen volumes. CT scan was performed if participant is not a candidate for MRI, or if MRI is not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=21 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=3 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=33 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=7 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ≥10% Reduction in Spleen Volume at Week 24 Compared to Baseline
|
42.9 percentage of participants
Interval 21.8 to 66.0
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
63.6 percentage of participants
Interval 45.1 to 79.6
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Efficacy evaluable participants included all participants enrolled and treated in the study.
Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=21 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=3 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=34 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=7 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 50% Improvement in Total Symptom Score as Measured by the Modified MFSAF V2.0 Diary at Week 24 Compared to Baseline
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
44.1 percentage of participants
Interval 27.2 to 62.1
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
—
|
SECONDARY outcome
Timeframe: Up to Week 156Population: Efficacy evaluable participants included all participants enrolled and treated in the study. 'Number Analyzed' is number of participants with data available at a particular time point.
Measurement of spleen length below the left costal margin was measured by palpation at each study visit. Investigators were provided with a soft centimeter ruler so that palpable spleen length was measured in centimeters and not in finger breadths. The edge of the spleen was determined by palpation, and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=21 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=4 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=34 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=7 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Change in Spleen Length Measured by Palpation
Baseline
|
11.48 cm
Standard Deviation 5.810
|
14.00 cm
Standard Deviation 4.359
|
13.13 cm
Standard Deviation 8.241
|
14.71 cm
Standard Deviation 6.726
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 4
|
-3.40 cm
Standard Deviation 3.068
|
-4.00 cm
Standard Deviation 6.083
|
-1.84 cm
Standard Deviation 3.195
|
0.00 cm
Standard Deviation 3.688
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 8
|
-4.65 cm
Standard Deviation 3.558
|
-5.33 cm
Standard Deviation 4.933
|
-2.81 cm
Standard Deviation 3.514
|
-1.14 cm
Standard Deviation 2.340
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 12
|
-4.53 cm
Standard Deviation 4.812
|
-6.50 cm
Standard Deviation 3.536
|
-3.74 cm
Standard Deviation 5.118
|
-3.71 cm
Standard Deviation 7.544
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 16
|
-3.79 cm
Standard Deviation 4.973
|
-4.50 cm
Standard Deviation 3.536
|
-3.69 cm
Standard Deviation 4.343
|
-2.00 cm
Standard Deviation 2.449
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 20
|
-4.56 cm
Standard Deviation 4.844
|
-7.50 cm
Standard Deviation 4.950
|
-5.28 cm
Standard Deviation 5.567
|
-3.50 cm
Standard Deviation 7.064
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 24
|
-4.25 cm
Standard Deviation 5.092
|
-7.00 cm
Standard Deviation 5.657
|
-4.57 cm
Standard Deviation 5.541
|
-1.33 cm
Standard Deviation 3.983
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 36
|
-7.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-11.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-2.75 cm
Standard Deviation 3.862
|
1.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 48
|
-7.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-11.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-2.33 cm
Standard Deviation 2.517
|
0.00 cm
Standard Deviation 0.000
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 60
|
-7.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-11.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-2.67 cm
Standard Deviation 2.517
|
1.50 cm
Standard Deviation 2.121
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 72
|
-4.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-11.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-1.50 cm
Standard Deviation 2.121
|
1.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 84
|
-4.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
-3.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-2.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 96
|
-4.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-8.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
0.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 108
|
-4.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-10.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
0.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 120
|
-4.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-6.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
2.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 132
|
-4.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-5.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
1.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 144
|
-4.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-3.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
0.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
|
Change in Spleen Length Measured by Palpation
Change at Week 156
|
-4.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-3.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
0.00 cm
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 156Population: Efficacy evaluable participants included all participants enrolled and treated in the study. 'Number Analyzed' is number of participants with data available at a particular time point.
Measurement of spleen length below the left costal margin was measured by palpation at each study visit. Investigators were provided with a soft centimeter ruler so that palpable spleen length was measured in centimeters and not in finger breadths. The edge of the spleen was determined by palpation, and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=21 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=4 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=34 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=7 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 4
|
-38.61 Percentage
Standard Deviation 36.532
|
-26.62 Percentage
Standard Deviation 36.906
|
-21.88 Percentage
Standard Deviation 33.800
|
-1.42 Percentage
Standard Deviation 22.902
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 8
|
-50.64 Percentage
Standard Deviation 39.930
|
-37.95 Percentage
Standard Deviation 28.772
|
-28.32 Percentage
Standard Deviation 31.151
|
-8.72 Percentage
Standard Deviation 13.991
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 12
|
-49.90 Percentage
Standard Deviation 48.623
|
-50.35 Percentage
Standard Deviation 8.348
|
-38.21 Percentage
Standard Deviation 39.936
|
-22.41 Percentage
Standard Deviation 40.833
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 16
|
-43.24 Percentage
Standard Deviation 48.173
|
-32.99 Percentage
Standard Deviation 15.222
|
-38.67 Percentage
Standard Deviation 36.070
|
-14.33 Percentage
Standard Deviation 14.903
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 20
|
-44.58 Percentage
Standard Deviation 46.490
|
-56.60 Percentage
Standard Deviation 17.187
|
-48.06 Percentage
Standard Deviation 38.826
|
-27.75 Percentage
Standard Deviation 39.024
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 24
|
-45.39 Percentage
Standard Deviation 53.913
|
-51.04 Percentage
Standard Deviation 25.043
|
-42.01 Percentage
Standard Deviation 36.899
|
-9.89 Percentage
Standard Deviation 25.001
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 36
|
-58.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-68.75 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-20.76 Percentage
Standard Deviation 27.637
|
5.00 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 48
|
-58.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-68.75 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-31.82 Percentage
Standard Deviation 19.285
|
0.00 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 60
|
-58.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-68.75 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-36.36 Percentage
Standard Deviation 12.856
|
15.00 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 72
|
-33.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-68.75 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-27.27 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
5.00 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 84
|
-33.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
-27.27 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-10.00 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 96
|
-33.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-50.00 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 108
|
-33.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-62.50 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 120
|
-33.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-37.50 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 132
|
-33.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-31.25 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 144
|
-33.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-18.75 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
—
|
|
Percent Change From Baseline in Spleen Length Measured by Palpation
Percent Change at Week 156
|
-33.33 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
-18.75 Percentage
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 156Population: Efficacy evaluable participants included all participants enrolled and treated in the study. 'Number Analyzed' is number of participants with data available at the particular time point.
Symptoms of myelofibrosis were assessed using the PGIC questionnaire. Using the questionnaire, patients rated the overall sense of treatment effect on their symptoms on a scale of 1 (very much improved)- 7(very much worse). The specific wording was: Since the start of the treatment you've received in this study, your myelofibrosis symptoms are: 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change, 5) Minimally worse, 6) Much worse, 7) Very much worse. A higher score indicates worse symptoms.
Outcome measures
| Measure |
5 mg QD or 5 mg BID
n=21 Participants
Participants received the final titrated dose of ruxolitinib 5 mg QD or 5 mg BID.
|
5 mg AM/ 10 mg PM
n=4 Participants
Participants received the final titrated dose of ruxolitinib 5 mg AM plus 10 mg PM.
|
10 mg BID
n=34 Participants
Participants received the final titrated dose of ruxolitinib 10 mg BID.
|
10 mg AM/ 15 mg PM or 15 mg BID
n=7 Participants
Participants received the final titrated dose of ruxolitinib 10 mg AM plus 15 mg PM or 15 mg BID.
|
>20 mg
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 4
|
2.8 score on a scale
Standard Deviation 0.89
|
2.8 score on a scale
Standard Deviation 1.26
|
2.6 score on a scale
Standard Deviation 1.09
|
3.3 score on a scale
Standard Deviation 0.76
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 8
|
2.7 score on a scale
Standard Deviation 1.22
|
2.3 score on a scale
Standard Deviation 0.96
|
2.2 score on a scale
Standard Deviation 0.99
|
2.9 score on a scale
Standard Deviation 0.69
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 12
|
2.4 score on a scale
Standard Deviation 0.96
|
2.3 score on a scale
Standard Deviation 1.15
|
2.2 score on a scale
Standard Deviation 1.17
|
3.4 score on a scale
Standard Deviation 1.27
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 16
|
2.4 score on a scale
Standard Deviation 0.83
|
2.0 score on a scale
Standard Deviation 1.00
|
1.9 score on a scale
Standard Deviation 0.91
|
3.3 score on a scale
Standard Deviation 0.95
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 20
|
2.4 score on a scale
Standard Deviation 0.86
|
2.3 score on a scale
Standard Deviation 0.58
|
1.9 score on a scale
Standard Deviation 1.11
|
2.3 score on a scale
Standard Deviation 0.82
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 24
|
2.9 score on a scale
Standard Deviation 1.27
|
2.3 score on a scale
Standard Deviation 0.58
|
1.9 score on a scale
Standard Deviation 0.98
|
2.0 score on a scale
Standard Deviation 1.00
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 36
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
3.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
1.8 score on a scale
Standard Deviation 0.50
|
2.5 score on a scale
Standard Deviation 0.71
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 48
|
—
|
2.5 score on a scale
Standard Deviation 0.71
|
1.3 score on a scale
Standard Deviation 0.58
|
2.0 score on a scale
Standard Deviation 0.00
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 60
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
2.5 score on a scale
Standard Deviation 0.71
|
1.7 score on a scale
Standard Deviation 0.58
|
3.0 score on a scale
Standard Deviation 0.00
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 72
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
2.5 score on a scale
Standard Deviation 0.71
|
—
|
4.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 84
|
—
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
1.0 score on a scale
Standard Deviation 0.00
|
3.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 96
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
2.5 score on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 108
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
2.5 score on a scale
Standard Deviation 0.71
|
1.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 120
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
2.5 score on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 132
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
3.0 score on a scale
Standard Deviation 1.41
|
1.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 144
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
2.5 score on a scale
Standard Deviation 0.71
|
1.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) Score at Each Visit
Week 156
|
2.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
3.0 score on a scale
Standard Deviation 1.41
|
1.0 score on a scale
Standard Deviation NA
Standard deviation was not estimated due to less number of participants.
|
—
|
—
|
Adverse Events
>0 - 5 mg
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
>5 - 10 mg
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
>10 - 15 mg
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
>15 - 20 mg
Serious events: 9 serious events
Other events: 31 other events
Deaths: 2 deaths
>20 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
>0 - 5 mg
n=15 participants at risk
Participants received ruxolitinib up to 5 mg.
|
>5 - 10 mg
n=66 participants at risk
Participants received ruxolitinib in the range of 5 to 10 mg.
|
>10 - 15 mg
n=54 participants at risk
Participants received ruxolitinib in the range of 10 to 15 mg.
|
>15 - 20 mg
n=44 participants at risk
Participants received ruxolitinib in the range of 15 to 20 mg.
|
>20 mg
n=9 participants at risk
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Cardiac disorders
Cardiac failure congestive
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Death
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
Other adverse events
| Measure |
>0 - 5 mg
n=15 participants at risk
Participants received ruxolitinib up to 5 mg.
|
>5 - 10 mg
n=66 participants at risk
Participants received ruxolitinib in the range of 5 to 10 mg.
|
>10 - 15 mg
n=54 participants at risk
Participants received ruxolitinib in the range of 10 to 15 mg.
|
>15 - 20 mg
n=44 participants at risk
Participants received ruxolitinib in the range of 15 to 20 mg.
|
>20 mg
n=9 participants at risk
Participants received ruxolitinib, more than 20 mg.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.1%
4/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.7%
2/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
3/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
10.6%
7/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
7.4%
4/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.4%
5/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Blood and lymphatic system disorders
Reticulocytosis
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
3/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
16.7%
11/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
7.4%
4/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Cardiac disorders
Cardiomegaly
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Cardiac disorders
Cyanosis
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.1%
4/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Eye disorders
Scleral haemorrhage
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Eye disorders
Visual impairment
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
5.6%
3/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
10.6%
7/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
13.0%
7/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.8%
3/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
9.1%
6/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.7%
2/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
9.1%
4/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
3/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.8%
3/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Asthenia
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
7.4%
4/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Early satiety
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.0%
2/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Fatigue
|
13.3%
2/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
10.6%
7/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
9.3%
5/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.8%
3/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Oedema
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.0%
2/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
13.6%
9/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
7.4%
4/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
13.6%
6/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Pain
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
5.6%
3/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.8%
3/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Hepatobiliary disorders
Cholelithiasis
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Oral herpes
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
3/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.7%
2/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
13.6%
6/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Infections and infestations
Vaginal infection
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
7.6%
5/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
5.6%
3/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Blast cell count increased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Blood creatinine decreased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Cardioactive drug level increased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Electrocardiogram QT prolonged
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Haemoglobin decreased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.8%
3/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Occult blood positive
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
3/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
5.6%
3/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.8%
3/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
Serum ferritin increased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
White blood cell count decreased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Investigations
White blood cell count increased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.0%
2/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
3/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.8%
3/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.1%
4/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
5.6%
3/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.0%
2/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.0%
2/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
3/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.8%
3/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.1%
4/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
5.6%
3/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Psychiatric disorders
Mental status changes
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Renal and urinary disorders
Urine flow decreased
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
3/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.7%
2/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
22.2%
2/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
2/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.7%
2/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.3%
2/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.7%
2/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.5%
1/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
1.9%
1/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.0%
2/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
2.3%
1/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
6.1%
4/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
22.2%
2/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
3.0%
2/66 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
0.00%
0/54 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
4.5%
2/44 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
11.1%
1/9 • Up to approximately 161 weeks
Safety evaluable population included participants who received at least 1 dose of study drug. Data for adverse events was reported as per the total daily dose the participant was receiving at the time of the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER