Trial Outcomes & Findings for Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy (NCT NCT04159415)
NCT ID: NCT04159415
Last Updated: 2025-11-17
Results Overview
Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2025-11-17
Participant Flow
Participant milestones
| Measure |
Treatment Sequence A, DBTP 1: Placebo SC QW
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants in treatment arm A received placebo subcutaneously (SC) once a week (QW) from day 1 to week 8.
|
Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants received low-dose REGN4461 SC QW from day 1 to week 8.
|
Treatment Sequence A, DBTP 2: Low-dose REGN4461 SC QW
Participants progressed from DBTP 1 to DBTP 2 (weeks 8 to 16). Here during DBTP 2, participants in treatment sequence A transitioned to receive low-dose REGN4461 SC QW from weeks 8 to 16.
|
Treatment Sequence B, DBTP 2: Medium-dose REGN4461 SC QW
Participants progressed from DBTP 1 to DBTP 2. Here during DBTP 2, participants in treatment sequence B transitioned to receive medium-dose REGN4461 SC QW from weeks 8 to 16.
|
Treatment Sequence A, DBTP 3: Medium-dose REGN4461 SC QW
Participants progressed from DBTP 2 to DBTP 3 (weeks 16 to 24). Here during DBTP 3, participants in treatment sequence A transitioned to receive medium-dose REGN4461 SC QW from weeks 16 to 24.
|
Treatment Sequence B, DBTP 3: Medium-dose REGN4461 SC QW
Participants progressed from DBTP 2 to DBTP 3. Here during DBTP 3, participants in treatment sequence B continued to receive medium-dose REGN4461 SC QW from weeks 16 to 24.
|
Treatment Sequence A, OLTP 4: Medium-dose REGN4461 SC QW
Following DBTP 3, participants in treatment sequence A, OLTP 4, continued to receive medium-dose REGN4461 SC QW from weeks 24 to 52 (completion of week 52 visit was considered end of study \[EOS\] for participants that did not continue to OLTP 5).
|
Treatment Sequence B, OLTP 4: Medium-dose REGN4461 SC QW
Following DBTP 3, participants in treatment sequence B, OLTP 4, continued to receive medium-dose REGN4461 SC QW from weeks 24 to 52 (completion of week 52 visit was considered EOS for participants that did not continue to OLTP 5).
|
Treatment Sequence A, OLTP 5: High-dose
Participants continuing on to OLTP 5 received high-dose REGN4461 SC QW for 52 weeks
|
Treatment Sequence B, OLTP 5: High-dose
Participants continuing on to OLTP 5 received high-dose REGN4461 SC QW for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double-blind Treatment Period (DBTP) 1
STARTED
|
8
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP) 1
COMPLETED
|
8
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP) 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP) 2
STARTED
|
0
|
0
|
8
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP) 2
COMPLETED
|
0
|
0
|
8
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP) 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP) 3
STARTED
|
0
|
0
|
0
|
0
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP) 3
COMPLETED
|
0
|
0
|
0
|
0
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period (DBTP) 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 4
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 4
Completed OLTP 4
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
8
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 4
Entered OLTP 4 Extension
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 4
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
4
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 5
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
4
|
|
Open-Label Treatment Period (OLTP) 5
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
3
|
|
Open-Label Treatment Period (OLTP) 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment Sequence A, DBTP 1: Placebo SC QW
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants in treatment arm A received placebo subcutaneously (SC) once a week (QW) from day 1 to week 8.
|
Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants received low-dose REGN4461 SC QW from day 1 to week 8.
|
Treatment Sequence A, DBTP 2: Low-dose REGN4461 SC QW
Participants progressed from DBTP 1 to DBTP 2 (weeks 8 to 16). Here during DBTP 2, participants in treatment sequence A transitioned to receive low-dose REGN4461 SC QW from weeks 8 to 16.
|
Treatment Sequence B, DBTP 2: Medium-dose REGN4461 SC QW
Participants progressed from DBTP 1 to DBTP 2. Here during DBTP 2, participants in treatment sequence B transitioned to receive medium-dose REGN4461 SC QW from weeks 8 to 16.
|
Treatment Sequence A, DBTP 3: Medium-dose REGN4461 SC QW
Participants progressed from DBTP 2 to DBTP 3 (weeks 16 to 24). Here during DBTP 3, participants in treatment sequence A transitioned to receive medium-dose REGN4461 SC QW from weeks 16 to 24.
|
Treatment Sequence B, DBTP 3: Medium-dose REGN4461 SC QW
Participants progressed from DBTP 2 to DBTP 3. Here during DBTP 3, participants in treatment sequence B continued to receive medium-dose REGN4461 SC QW from weeks 16 to 24.
|
Treatment Sequence A, OLTP 4: Medium-dose REGN4461 SC QW
Following DBTP 3, participants in treatment sequence A, OLTP 4, continued to receive medium-dose REGN4461 SC QW from weeks 24 to 52 (completion of week 52 visit was considered end of study \[EOS\] for participants that did not continue to OLTP 5).
|
Treatment Sequence B, OLTP 4: Medium-dose REGN4461 SC QW
Following DBTP 3, participants in treatment sequence B, OLTP 4, continued to receive medium-dose REGN4461 SC QW from weeks 24 to 52 (completion of week 52 visit was considered EOS for participants that did not continue to OLTP 5).
|
Treatment Sequence A, OLTP 5: High-dose
Participants continuing on to OLTP 5 received high-dose REGN4461 SC QW for 52 weeks
|
Treatment Sequence B, OLTP 5: High-dose
Participants continuing on to OLTP 5 received high-dose REGN4461 SC QW for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Open-Label Treatment Period (OLTP) 4
Completed Wk 52; did not enter OLTP 4 extension
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 4
Lost to follow-up during OLTP 4 extension
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 4
Completed Wk 52; discontinued during OLTP4 Ext. PI/Participant decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open-Label Treatment Period (OLTP) 5
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
Baseline characteristics by cohort
| Measure |
Treatment Sequence A, DBTP 1-3
n=8 Participants
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24).
|
Treatment Sequence B, DBTP 1 -3
n=8 Participants
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24).
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.8 Years
STANDARD_DEVIATION 4.95 • n=39 Participants
|
30.3 Years
STANDARD_DEVIATION 16.06 • n=29 Participants
|
25.0 Years
STANDARD_DEVIATION 12.70 • n=60 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
8 Participants
n=29 Participants
|
14 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
4 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=39 Participants
|
7 Participants
n=29 Participants
|
12 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
11 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c \[HbA1c ≥7%\])
Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8
|
0.2 millimoles per mole (mmol/mol)
Standard Error 0.7
|
-0.1 millimoles per mole (mmol/mol)
Standard Error 0.6
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c \[HbA1c ≥7%\])
Absolute change from baseline in fasting glucose for subgroup of participants with baseline HbA1c ≥7% reported
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in Fasting Glucose at Week 8
|
53.6 milligrams per deciliter (mg/dL)
Standard Error 19.9
|
15.5 milligrams per deciliter (mg/dL)
Standard Error 18.6
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c \[HbA1c ≥7%\])
Absolute change from baseline in WMG for subgroup of participants with baseline HbA1c ≥7% reported
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8
|
-3.7 mg/dL
Standard Error 23.4
|
-3.7 mg/dL
Standard Error 19.9
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Triglyceride analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline fasting TG (TG ≥250 mg/dL)
Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported
Outcome measures
| Measure |
Treatment Sequence B
n=6 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=6 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 8
|
11.8 percentage of change
Standard Error 29.8
|
-6.0 percentage of change
Standard Error 29.8
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Subgroup of participants with baseline HbA1c ≥ 7% or TG ≥ 250 mg/dL
The composite score is calculated for each individual participant using baseline and Week 8 measurements of HbA1c and fasting TG. For each participant, a Z-score is calculated separately for HbA1c and fasting TG, rescaling the change from baseline based on the standard deviation of the baseline value for all participants, as a way of standardizing the change value. The composite score uses one or both of the calculated Z-scores depending on which parameters were abnormal at baseline. If both, then the participant's composite is the average of the two parameter Z-scores. At the participant level, a Z-score of zero for either parameter indicates no change in that metabolic parameter, but a composite Z-score of zero can also reflect offsetting changes in metabolic parameters. A negative Z-score would be interpreted as an overall improvement in metabolic function, but a negative Z-score can also result from a decrease in one parameter not being canceled by an increase in the other.
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8
|
0.1 Z-score
Standard Error 0.3
|
0.0 Z-score
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in Fasting Glucose
Week 52
|
6.9 mg/dL
Standard Deviation 68.64
|
-55.1 mg/dL
Standard Deviation 77.97
|
|
Absolute Change From Baseline in Fasting Glucose
OLTP 5 Week 4
|
-39.8 mg/dL
Standard Deviation 45.36
|
-91.8 mg/dL
Standard Deviation 61.29
|
|
Absolute Change From Baseline in Fasting Glucose
OLTP 5 Week 12
|
-119.9 mg/dL
Standard Deviation 64.64
|
-82.9 mg/dL
Standard Deviation 63.16
|
|
Absolute Change From Baseline in Fasting Glucose
OLTP 5 Week 24
|
-40.7 mg/dL
Standard Deviation 110.20
|
-100.5 mg/dL
Standard Deviation 55.15
|
|
Absolute Change From Baseline in Fasting Glucose
OLTP 5 Week 52
|
-111.2 mg/dL
Standard Deviation 125.57
|
-91.0 mg/dL
Standard Deviation 84.38
|
|
Absolute Change From Baseline in Fasting Glucose
Week 16
|
-22.0 mg/dL
Standard Deviation 47.85
|
-29.4 mg/dL
Standard Deviation 59.80
|
|
Absolute Change From Baseline in Fasting Glucose
Week 24
|
-21.1 mg/dL
Standard Deviation 82.85
|
-68.8 mg/dL
Standard Deviation 58.74
|
|
Absolute Change From Baseline in Fasting Glucose
Week 36
|
12.5 mg/dL
Standard Deviation 119.63
|
-47.6 mg/dL
Standard Deviation 71.04
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
Week 16
|
-26.3 mg/dL
Standard Deviation 50.89
|
-29.4 mg/dL
Standard Deviation 59.80
|
|
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
Week 24
|
-24.5 mg/dL
Standard Deviation 90.23
|
-68.8 mg/dL
Standard Deviation 58.74
|
|
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
Week 36
|
13.1 mg/dL
Standard Deviation 129.20
|
-47.6 mg/dL
Standard Deviation 71.04
|
|
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
Week 52
|
8.2 mg/dL
Standard Deviation 75.10
|
-55.1 mg/dL
Standard Deviation 77.97
|
|
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
OLTP 5 Week 4
|
-39.8 mg/dL
Standard Deviation 45.36
|
-91.8 mg/dL
Standard Deviation 61.29
|
|
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
OLTP 5 Week 12
|
-119.9 mg/dL
Standard Deviation 64.64
|
-82.9 mg/dL
Standard Deviation 63.16
|
|
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
OLTP 5 Week 24
|
-40.7 mg/dL
Standard Deviation 110.20
|
-100.5 mg/dL
Standard Deviation 55.15
|
|
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
OLTP 5 Week 52
|
-111.2 mg/dL
Standard Deviation 125.57
|
-91.0 mg/dL
Standard Deviation 84.38
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Percent Change From Baseline in Fasting TG
Week 16
|
-50.2 Percentage of change
Standard Deviation 39.99
|
-22.5 Percentage of change
Standard Deviation 48.21
|
|
Percent Change From Baseline in Fasting TG
Week 24
|
-45.7 Percentage of change
Standard Deviation 44.61
|
-55.1 Percentage of change
Standard Deviation 30.60
|
|
Percent Change From Baseline in Fasting TG
Week 36
|
-43.9 Percentage of change
Standard Deviation 51.07
|
-40.2 Percentage of change
Standard Deviation 39.19
|
|
Percent Change From Baseline in Fasting TG
Week 52
|
-60.3 Percentage of change
Standard Deviation 20.38
|
-9.7 Percentage of change
Standard Deviation 74.05
|
|
Percent Change From Baseline in Fasting TG
OLTP 5 Week 4
|
-58.2 Percentage of change
Standard Deviation 21.60
|
-71.5 Percentage of change
Standard Deviation 18.79
|
|
Percent Change From Baseline in Fasting TG
OLTP 5 Week 12
|
-80.0 Percentage of change
Standard Deviation 17.52
|
-56.0 Percentage of change
Standard Deviation 38.07
|
|
Percent Change From Baseline in Fasting TG
OLTP 5 Week 24
|
-67.4 Percentage of change
Standard Deviation 22.32
|
-64.4 Percentage of change
Standard Deviation 29.59
|
|
Percent Change From Baseline in Fasting TG
OLTP 5 Week 52
|
-85.8 Percentage of change
Standard Deviation 11.89
|
-77.4 Percentage of change
Standard Deviation 13.37
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=6 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=6 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
Week 16
|
-45.4 Percentage of change
Standard Deviation 47.97
|
-39.4 Percentage of change
Standard Deviation 36.26
|
|
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
Week 24
|
-42.4 Percentage of change
Standard Deviation 53.75
|
-62.8 Percentage of change
Standard Deviation 30.80
|
|
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
Week 36
|
-44.0 Percentage of change
Standard Deviation 60.31
|
-48.6 Percentage of change
Standard Deviation 41.67
|
|
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
Week 52
|
-63.4 Percentage of change
Standard Deviation 22.22
|
0.7 Percentage of change
Standard Deviation 85.36
|
|
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
OLTP 5 Week 4
|
-58.2 Percentage of change
Standard Deviation 21.60
|
-72.2 Percentage of change
Standard Deviation 20.92
|
|
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
OLTP 5 Week 12
|
-80.0 Percentage of change
Standard Deviation 17.52
|
-54.9 Percentage of change
Standard Deviation 42.46
|
|
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
OLTP 5 Weeks 24
|
-67.4 Percentage of change
Standard Deviation 22.32
|
-64.0 Percentage of change
Standard Deviation 33.06
|
|
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
OLTP 5 Week 52
|
-85.8 Percentage of change
Standard Deviation 11.89
|
-77.4 Percentage of change
Standard Deviation 13.37
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in HbA1c
OLTP 5 Week 12
|
-1.53 Percentage of HbA1c
Standard Deviation 2.472
|
-3.57 Percentage of HbA1c
Standard Deviation 1.957
|
|
Absolute Change From Baseline in HbA1c
OLTP 5 Week 24
|
-1.45 Percentage of HbA1c
Standard Deviation 2.716
|
-3.32 Percentage of HbA1c
Standard Deviation 2.294
|
|
Absolute Change From Baseline in HbA1c
OLTP 5 Week 52
|
-3.30 Percentage of HbA1c
Standard Deviation 2.821
|
-1.67 Percentage of HbA1c
Standard Deviation 3.066
|
|
Absolute Change From Baseline in HbA1c
Week 16
|
-0.50 Percentage of HbA1c
Standard Deviation 1.664
|
-0.60 Percentage of HbA1c
Standard Deviation 2.200
|
|
Absolute Change From Baseline in HbA1c
Week 24
|
-0.85 Percentage of HbA1c
Standard Deviation 1.998
|
-2.34 Percentage of HbA1c
Standard Deviation 1.897
|
|
Absolute Change From Baseline in HbA1c
Week 36
|
-0.83 Percentage of HbA1c
Standard Deviation 2.147
|
-2.56 Percentage of HbA1c
Standard Deviation 1.985
|
|
Absolute Change From Baseline in HbA1c
Week 52
|
-1.59 Percentage of HbA1c
Standard Deviation 2.338
|
-2.69 Percentage of HbA1c
Standard Deviation 2.120
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
OLTP 5 Week 24
|
-1.45 Percentage of HbA1c
Standard Deviation 2.716
|
-3.32 Percentage of HbA1c
Standard Deviation 2.294
|
|
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
OLTP 5 Week 52
|
-3.30 Percentage of HbA1c
Standard Deviation 2.821
|
-1.67 Percentage of HbA1c
Standard Deviation 3.066
|
|
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
Week 52
|
-1.65 Percentage of HbA1c
Standard Deviation 2.554
|
-2.69 Percentage of HbA1c
Standard Deviation 2.120
|
|
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
OLTP 5 Week 12
|
-1.53 Percentage of HbA1c
Standard Deviation 2.472
|
-3.57 Percentage of HbA1c
Standard Deviation 1.957
|
|
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
Week 16
|
-0.36 Percentage of HbA1c
Standard Deviation 1.820
|
-0.60 Percentage of HbA1c
Standard Deviation 2.200
|
|
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
Week 24
|
-0.77 Percentage of HbA1c
Standard Deviation 2.145
|
-2.34 Percentage of HbA1c
Standard Deviation 1.897
|
|
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
Week 36
|
-0.74 Percentage of HbA1c
Standard Deviation 2.305
|
-2.56 Percentage of HbA1c
Standard Deviation 1.985
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16 and 24Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in Weighted Mean Glucose (WMG)
Week 24
|
-49.107 mg/dL
Standard Deviation 85.0349
|
-73.634 mg/dL
Standard Deviation 67.7436
|
|
Absolute Change From Baseline in Weighted Mean Glucose (WMG)
Week 16
|
-7.579 mg/dL
Standard Deviation 96.4257
|
-10.626 mg/dL
Standard Deviation 28.6416
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16 and 24Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Absolute Change From Baseline in WMG for Participants With Baseline Fasting HbA1c ≥7%
Week 16
|
-4.510 mg/dL
Standard Deviation 111.0606
|
-10.626 mg/dL
Standard Deviation 28.6416
|
|
Absolute Change From Baseline in WMG for Participants With Baseline Fasting HbA1c ≥7%
Week 24
|
-53.797 mg/dL
Standard Deviation 92.1541
|
-73.634 mg/dL
Standard Deviation 67.7436
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Change From Baseline in Glucose Area Under the Concentration-time Curve (AUC0-4) During a Mixed Meal Tolerance Test (MMTT)
Week 8
|
1479.3 mg/dL*minutes
Standard Deviation 6075.13
|
829.3 mg/dL*minutes
Standard Deviation 12465.83
|
|
Change From Baseline in Glucose Area Under the Concentration-time Curve (AUC0-4) During a Mixed Meal Tolerance Test (MMTT)
Week 16
|
3734.1 mg/dL*minutes
Standard Deviation 22343.37
|
-5300.7 mg/dL*minutes
Standard Deviation 12605.15
|
|
Change From Baseline in Glucose Area Under the Concentration-time Curve (AUC0-4) During a Mixed Meal Tolerance Test (MMTT)
Week 24
|
-5777.7 mg/dL*minutes
Standard Deviation 14328.54
|
-18000.6 mg/dL*minutes
Standard Deviation 14760.99
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 16, 24Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Change From Baseline in Glucose AUC0-4 During a MMTT for Participants With Baseline HbA1c ≥7%
Week 8
|
3098.2 mg/dL*minutes
Standard Deviation 5145.73
|
829.3 mg/dL*minutes
Standard Deviation 12465.83
|
|
Change From Baseline in Glucose AUC0-4 During a MMTT for Participants With Baseline HbA1c ≥7%
Week 16
|
5976.4 mg/dL*minutes
Standard Deviation 25141.92
|
-5300.7 mg/dL*minutes
Standard Deviation 12605.15
|
|
Change From Baseline in Glucose AUC0-4 During a MMTT for Participants With Baseline HbA1c ≥7%
Week 24
|
-5828.2 mg/dL*minutes
Standard Deviation 15695.44
|
-18000.6 mg/dL*minutes
Standard Deviation 14760.99
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Change From Baseline in Glucose Infusion Rate Per Kilogram (kg) Body Mass During Hyperinsulinemia-euglycemic Clamp
Week 8
|
4.789 mg/kg/min
Standard Deviation 7.3736
|
0.030 mg/kg/min
Standard Deviation 0.4224
|
|
Change From Baseline in Glucose Infusion Rate Per Kilogram (kg) Body Mass During Hyperinsulinemia-euglycemic Clamp
Week 52
|
4.776 mg/kg/min
Standard Deviation 3.0924
|
6.256 mg/kg/min
Standard Deviation NA
NA = SD not calculable (1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Change From Baseline in Glucose Infusion Rate Per kg Body Mass During Hyperinsulinemia-euglycemic Clamp for Participants With Baseline HbA1c ≥7%
Week 8
|
0.572 mg/kg/min
Standard Deviation 1.4186
|
0.030 mg/kg/min
Standard Deviation 0.4224
|
|
Change From Baseline in Glucose Infusion Rate Per kg Body Mass During Hyperinsulinemia-euglycemic Clamp for Participants With Baseline HbA1c ≥7%
Week 52
|
3.740 mg/kg/min
Standard Deviation 2.8121
|
6.256 mg/kg/min
Standard Deviation NA
NA = SD not calculable (1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Change From Baseline in Glucose Clearance Rate (kITT) During Insulin-tolerance Test (ITT)
Week 8
|
2.230 %mg/dL/min
Standard Deviation 2.4771
|
0.021 %mg/dL/min
Standard Deviation NA
NA = SD not calculable (1 participant)
|
|
Change From Baseline in Glucose Clearance Rate (kITT) During Insulin-tolerance Test (ITT)
Week 52
|
0.632 %mg/dL/min
Standard Deviation 0.2064
|
2.311 %mg/dL/min
Standard Deviation 0.1712
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=7 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Change From Baseline in Glucose kITT During ITT for Participants With Baseline HbA1c ≥7%
Week 8
|
2.230 %mg/dL/min
Standard Deviation 2.4771
|
0.021 %mg/dL/min
Standard Deviation NA
NA = SD not calculable (1 participant)
|
|
Change From Baseline in Glucose kITT During ITT for Participants With Baseline HbA1c ≥7%
Week 52
|
0.632 %mg/dL/min
Standard Deviation 0.2064
|
2.311 %mg/dL/min
Standard Deviation 0.1712
|
SECONDARY outcome
Timeframe: From first dose of DBTP study treatment through last dose of OLTP 5 study treatment plus 16 weeks (approximately 120 weeks)Population: Double-blind Safety Analysis Set (DBTP SAF): Randomized participants who received any double-blind study drug; OLTP safety analysis set for Period 4 (OLTP 4 SAF): Randomized participants who received any open-label treatment period 4 study drug; OLTP 5 SAF: Randomized participants who received any open-label treatment period 5 study drug.
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
DBTP 1-3
|
8 Participants
|
7 Participants
|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
OLTP 4
|
7 Participants
|
8 Participants
|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
OLTP 5
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 (post-dose), 8, 16 (post-dose), 36, 52; OLTP 5 Weeks 4, 12, 24, 52Population: Number Analyzed equals number of participants analyzed at each time point
Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Concentrations of Total REGN4461 in Serum Over Time
Week 0 (post-dose)
|
49.2 mg/L
Standard Deviation 13.8
|
0 mg/L
Standard Deviation 0
|
|
Concentrations of Total REGN4461 in Serum Over Time
Week 8
|
2.51 mg/L
Standard Deviation 3.11
|
45.8 mg/L
Standard Deviation 6.82
|
|
Concentrations of Total REGN4461 in Serum Over Time
Week 16 (post-dose)
|
50.6 mg/L
Standard Deviation 38.7
|
2.34 mg/L
Standard Deviation 3.44
|
|
Concentrations of Total REGN4461 in Serum Over Time
Week 36
|
67.7 mg/L
Standard Deviation 44.2
|
54.3 mg/L
Standard Deviation 36.4
|
|
Concentrations of Total REGN4461 in Serum Over Time
Week 52
|
68.8 mg/L
Standard Deviation 41.2
|
60.1 mg/L
Standard Deviation 45.1
|
|
Concentrations of Total REGN4461 in Serum Over Time
OLTP 5 Week 4
|
167 mg/L
Standard Deviation 60.6
|
167 mg/L
Standard Deviation 72.2
|
|
Concentrations of Total REGN4461 in Serum Over Time
OLTP5 Week 12
|
194 mg/L
Standard Deviation 80.6
|
185 mg/L
Standard Deviation 67.2
|
|
Concentrations of Total REGN4461 in Serum Over Time
OLTP5 Week 36
|
355 mg/L
Standard Deviation 166
|
156 mg/L
Standard Deviation 77.0
|
|
Concentrations of Total REGN4461 in Serum Over Time
OLTP5 Week 52
|
378 mg/L
Standard Deviation 224
|
196 mg/L
Standard Deviation 106
|
SECONDARY outcome
Timeframe: Approximately Week 128Outcome measures
| Measure |
Treatment Sequence B
n=8 Participants
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
Treatment Sequence A
n=8 Participants
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
|
|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA) to REGN4461
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment Sequence B: OLTP 5
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment Sequence A: DBTP 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment Sequence B: DBTP 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment Sequence A: DBTP 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment Sequence B: DBTP 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment Sequence A: DBTP 3
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Sequence B: DBTP 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment Sequence A: OLTP 4
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment Sequence B: OLTP 4
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment Sequence A: OLTP 5
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Sequence B: OLTP 5
n=4 participants at risk
Participants continuing on to OLTP 5 received High-dose REGN4461 SC QW for 51 weeks
|
Treatment Sequence A: DBTP 1
n=8 participants at risk
Placebo SC QW from day 1 to week 8
|
Treatment Sequence B: DBTP 1
n=8 participants at risk
Low-dose REGN4461 SC QW from day 1 to week 8
|
Treatment Sequence A: DBTP 2
n=8 participants at risk
Low-dose REGN4461 SC QW from weeks 8 to 16
|
Treatment Sequence B: DBTP 2
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 8 to 16
|
Treatment Sequence A: DBTP 3
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 16 to 24
|
Treatment Sequence B: DBTP 3
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 16 to 24
|
Treatment Sequence A: OLTP 4
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 24 to 52
|
Treatment Sequence B: OLTP 4
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 24 to 52
|
Treatment Sequence A: OLTP 5
n=6 participants at risk
Participants continuing on to OLTP 5 received High-dose REGN4461 SC QW for 51 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Cardiac disorders
Cardiac failure
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
Other adverse events
| Measure |
Treatment Sequence B: OLTP 5
n=4 participants at risk
Participants continuing on to OLTP 5 received High-dose REGN4461 SC QW for 51 weeks
|
Treatment Sequence A: DBTP 1
n=8 participants at risk
Placebo SC QW from day 1 to week 8
|
Treatment Sequence B: DBTP 1
n=8 participants at risk
Low-dose REGN4461 SC QW from day 1 to week 8
|
Treatment Sequence A: DBTP 2
n=8 participants at risk
Low-dose REGN4461 SC QW from weeks 8 to 16
|
Treatment Sequence B: DBTP 2
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 8 to 16
|
Treatment Sequence A: DBTP 3
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 16 to 24
|
Treatment Sequence B: DBTP 3
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 16 to 24
|
Treatment Sequence A: OLTP 4
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 24 to 52
|
Treatment Sequence B: OLTP 4
n=8 participants at risk
Medium-dose REGN4461 SC QW from weeks 24 to 52
|
Treatment Sequence A: OLTP 5
n=6 participants at risk
Participants continuing on to OLTP 5 received High-dose REGN4461 SC QW for 51 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Hyperthermia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Inflammation
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Vitamin D decreased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Waist circumference increased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Blood pressure decreased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Body temperature increased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Echocardiogram abnormal
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Fungal test positive
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Weight increased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
37.5%
3/8 • Number of events 3 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Antibiotic associated colitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Conjunctivitis
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Ear lobe infection
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 3 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Otosalpingitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Pustule
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Nervous system disorders
Sudden onset of sleep
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Reactive perforating collagenosis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Blood and lymphatic system disorders
Deficiency anaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Cardiac disorders
Mitral valve stenosis
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Chest pain
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Chills
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Cyst
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
25.0%
1/4 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 3 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
37.5%
3/8 • Number of events 4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
37.5%
3/8 • Number of events 3 • From first dose of study drug through end of study (approximately 128 weeks)
|
50.0%
4/8 • Number of events 23 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 3 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 3 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 5 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Nail fold inflammation
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Eye disorders
Astigmatism
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Eye disorders
Myopia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
General disorders
Asthenia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Vascular disorders
Labile hypertension
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
37.5%
3/8 • Number of events 4 • From first dose of study drug through end of study (approximately 128 weeks)
|
33.3%
2/6 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
16.7%
1/6 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 3 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Injury of conjunctiva
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
25.0%
2/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Osteophyte fracture
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 2 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Investigations
Blood potassium decreased
|
25.0%
1/4 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
0.00%
0/4 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
12.5%
1/8 • Number of events 1 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/8 • From first dose of study drug through end of study (approximately 128 weeks)
|
0.00%
0/6 • From first dose of study drug through end of study (approximately 128 weeks)
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER