Trial Outcomes & Findings for Study of BHV-3241 in Participants With Multiple System Atrophy (NCT NCT03952806)
NCT ID: NCT03952806
Last Updated: 2023-09-29
Results Overview
UMSARS - clinician-rated scale comprised of 4 parts: Part I (Historical Review), Part II (Motor Examination), Part III (Autonomic Examination), Part IV (Global Disability Scale). Modified UMSARS is composed of subset of 9 items from original UMSARS Part I and Part II. Responses are measured on 4-point scale ranged from 0-3, where 0= no/mild impairment, 1= moderate impairment, 2= severe impairment, 3=complete impairment. Total modified UMSARS score is sum of these 9 items, score range from 0 to 27. Higher scores indicate greater impairment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
421 participants
Primary outcome timeframe
Baseline and Week 48
Results posted on
2023-09-29
Participant Flow
This Phase 3, randomized, double-blind, placebo-controlled study was conducted in participants with multiple system atrophy (MSA) at 48 centers in the US and EU between 29-Jul-2019 and 29-Jul-2021.
A total of 421 participants were enrolled, of which 336 participants were randomized in a 1:1: ratio to receive verdiperstat or placebo. 85 participants were not randomized due to withdrawal of consent, adverse events, failed inclusion/exclusion criteria, or other reasons.
Participant milestones
| Measure |
Verdiperstat
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 milligrams (mg) tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
Open-label extension (OLE) phase (48 weeks): Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
OLE phase (48 weeks): Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|
|
Randomization Phase (Weeks 1 Through 48)
STARTED
|
168
|
168
|
|
Randomization Phase (Weeks 1 Through 48)
COMPLETED
|
127
|
146
|
|
Randomization Phase (Weeks 1 Through 48)
NOT COMPLETED
|
41
|
22
|
|
OLE Phase (48 Weeks)
STARTED
|
123
|
140
|
|
OLE Phase (48 Weeks)
COMPLETED
|
44
|
46
|
|
OLE Phase (48 Weeks)
NOT COMPLETED
|
79
|
94
|
Reasons for withdrawal
| Measure |
Verdiperstat
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 milligrams (mg) tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
Open-label extension (OLE) phase (48 weeks): Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
OLE phase (48 weeks): Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|
|
Randomization Phase (Weeks 1 Through 48)
Adverse Event
|
26
|
15
|
|
Randomization Phase (Weeks 1 Through 48)
Disease progression
|
5
|
0
|
|
Randomization Phase (Weeks 1 Through 48)
Participant request
|
5
|
5
|
|
Randomization Phase (Weeks 1 Through 48)
Withdrawal by Subject
|
4
|
2
|
|
Randomization Phase (Weeks 1 Through 48)
Other
|
1
|
0
|
|
OLE Phase (48 Weeks)
Adverse Event
|
18
|
29
|
|
OLE Phase (48 Weeks)
Disease Progression
|
6
|
9
|
|
OLE Phase (48 Weeks)
Participant Request to Discontinue
|
35
|
38
|
|
OLE Phase (48 Weeks)
Withdrawal by Subject
|
4
|
5
|
|
OLE Phase (48 Weeks)
Other
|
16
|
13
|
Baseline Characteristics
Study of BHV-3241 in Participants With Multiple System Atrophy
Baseline characteristics by cohort
| Measure |
Verdiperstat
n=168 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
OLE phase (48 weeks): Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo
n=168 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
OLE phase (48 weeks): Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
Total
n=336 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 7.12 • n=93 Participants
|
60.1 years
STANDARD_DEVIATION 6.68 • n=4 Participants
|
61.3 years
STANDARD_DEVIATION 6.99 • n=27 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
166 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
170 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
163 Participants
n=93 Participants
|
163 Participants
n=4 Participants
|
326 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
155 Participants
n=93 Participants
|
156 Participants
n=4 Participants
|
311 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Unified Multiple System Atrophy Rating Scale (UMSARS) Modified Score
|
6.1 units on a scale
STANDARD_DEVIATION 4.24 • n=93 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 3.74 • n=4 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 3.99 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: Modified Intent to Treat (mITT) population included randomized participants who received at least 1 dose of blinded study therapy and provided a baseline and at least 1 post-baseline efficacy assessment.
UMSARS - clinician-rated scale comprised of 4 parts: Part I (Historical Review), Part II (Motor Examination), Part III (Autonomic Examination), Part IV (Global Disability Scale). Modified UMSARS is composed of subset of 9 items from original UMSARS Part I and Part II. Responses are measured on 4-point scale ranged from 0-3, where 0= no/mild impairment, 1= moderate impairment, 2= severe impairment, 3=complete impairment. Total modified UMSARS score is sum of these 9 items, score range from 0 to 27. Higher scores indicate greater impairment.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=125 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=140 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Modified UMSARS Score at Week 48
|
5.20 units on a scale
Interval 4.52 to 5.89
|
4.85 units on a scale
Interval 4.19 to 5.51
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 100 weeksPopulation: Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, or, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=168 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=168 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
n=123 Participants
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
n=140 Participants
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAE
|
160 participants
|
156 participants
|
95 participants
|
112 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAE
|
44 participants
|
29 participants
|
30 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Week 48Population: mITT population.
The CGI-I is a clinician-rated scale measuring the change in the participant's clinical status from a specific point in time. It is scored on a 7- point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change. Higher scores indicate greater impairment.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=126 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=142 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I) Score at Week 48
|
5.07 units on a scale
Interval 4.92 to 5.21
|
5.14 units on a scale
Interval 5.0 to 5.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: mITT population.
The MSA-QoL is a participant-rated scale that was designed to measure health-related quality of life specifically in MSA. It assesses activities of daily living and has subscales for motor, nonmotor, and emotional/social domains. The MSA-QoL motor subscale includes 14 items. The response to each question ranges from 0= no problem, to 4= extreme problem, with a total scale ranging from 0-56. Higher scores indicates higher impact of the disease on the aspect measured by each subscale.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=114 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=130 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Motor Subscale at Week 48
|
13.83 units on a scale
Interval 10.97 to 16.69
|
13.45 units on a scale
Interval 10.72 to 16.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: mITT population.
The MSA-QoL is a participant-rated scale that was designed to measure health-related quality of life specifically in MSA. It assesses activities of daily living and has subscales for motor, nonmotor, and emotional/social domains. The MSA-QoL nonmotor subscale includes 12 items. The response to each question ranges from 0= no problem, to 4= extreme problem, with a total scale ranging from 0-48. Higher scores indicates higher impact of the disease on the aspect measured by each subscale.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=116 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=128 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Non-motor Subscale at Week 48
|
7.52 units on a scale
Interval 4.93 to 10.11
|
5.56 units on a scale
Interval 3.07 to 8.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: mITT population.
The UMSARS is a clinician-rated scale comprised of 4 parts: Part I (Historical Review with 12 questions), Part II (Motor Examination with 14 questions), Part III (Autonomic Examination), and Part IV (Global Disability Scale). UMSARS Part I and Part II responses are measured on a 5-point scale ranging from 0 to 4, where 0= no impairment, 1= mild impairment, 2= moderate impairment, 3= severe impairment, 4=complete impairment. Each subscale score is a sum of its items and total score is sum of all 26 items, score range from 0 to 104. Higher scores indicates greater impairment.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=125 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=139 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in UMSARS Part I and Part II Total Score at Week 48
|
12.00 units on a scale
Interval 10.37 to 13.63
|
11.34 units on a scale
Interval 9.77 to 12.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: mITT population.
The PGI-S is a participant-rated scale that measures how participants perceive the severity of their illness. The PGI-S is a 1-item questionnaire on a 4-point scale ranging from 1 to 4, where, 1 = normal, 2 = mild, 3 = moderate, 4 = severe. Higher scores indicate greater impairment.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=125 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=142 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) at Week 48
|
0.33 units on a scale
Interval 0.23 to 0.42
|
0.27 units on a scale
Interval 0.18 to 0.36
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: mITT population.
The CGI-S is a clinician-rated scale measuring the severity of the participant's illness. It is scored on a 7- point scale ranging from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). Higher scores indicate greater impairment.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=126 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=142 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression of Severity (CGI-S) at Week 48
|
0.79 units on a scale
Interval 0.66 to 0.92
|
0.78 units on a scale
Interval 0.66 to 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: mITT population.
The UMSARS is a clinician-rated scale comprised of 4 parts: Part I (Historical Review), Part II (Motor Examination), Part III (Autonomic Examination) and Part IV (Global Disability Scale). Only Part III of UMSARS was analyzed. Part III of the UMSARS is an Autonomic Exam, consisting of Supine and Standing Systolic and Diastolic Blood Pressure, Heart rate and presence Orthostatic Symptoms. Only change in Orthostatic Blood Pressure reported.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=118 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=132 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in UMSARS Part III at Week 48 (Blood Pressure (BP) Only)
Change in Orthostatic Systolic BP
|
-2.18 millimeter of mercury
Interval -5.9 to 1.55
|
-3.09 millimeter of mercury
Interval -6.63 to 0.44
|
—
|
—
|
|
Change From Baseline in UMSARS Part III at Week 48 (Blood Pressure (BP) Only)
Change in Orthostatic Diastolic BP
|
-2.87 millimeter of mercury
Interval -5.13 to -0.61
|
-2.54 millimeter of mercury
Interval -4.7 to -0.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: mITT population.
The UMSARS is a clinician-rated scale comprised of 4 parts: Part I (Historical Review), Part II (Motor Examination), Part III (Autonomic Examination) and Part IV (Global Disability Scale). Only Part III of UMSARS was analyzed. Part III of the UMSARS is an Autonomic Exam, consisting of Supine and Standing Systolic and Diastolic Blood Pressure, Heart rate and presence Orthostatic Symptoms. Only change in Orthostatic Heart Rate reported.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=119 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=132 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in UMSARS Part III at Week 48 (Heart Rate (HR) Only)
|
0.20 beats per minute
Interval -1.48 to 1.87
|
-0.68 beats per minute
Interval -2.27 to 0.91
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: mITT population.
The UMSARS is a clinician-rated scale comprised of 4 parts: Part I (Historical Review), Part II (Motor Examination), Part III (Autonomic Examination) and Part IV (Global Disability Scale). Only Part IV of UMSARS was analyzed. Part IV was measured on a 5-point scale ranging from 1= Completely independent. Able to do all chores with minimal difficulty or impairment. Essentially normal. Unaware of any difficulty, to 5= Totally dependent and helpless. Bedridden. Higher scores indicate greater impairment.
Outcome measures
| Measure |
Verdiperstat - Randomization Phase
n=126 Participants
Randomization phase (Randomization through Week 48): Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=140 Participants
Randomization phase (Randomization through Week 48): Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/ Verdiperstat - OLE Phase
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in UMSARS Part IV at Week 48
|
0.82 units on a scale
Interval 0.69 to 0.96
|
0.85 units on a scale
Interval 0.72 to 0.99
|
—
|
—
|
Adverse Events
Verdiperstat - Randomization Phase
Serious events: 44 serious events
Other events: 125 other events
Deaths: 11 deaths
Placebo - Randomization Phase
Serious events: 29 serious events
Other events: 130 other events
Deaths: 5 deaths
Verdiperstat - Randomization Phase/Verdiperstat - OLE Phase
Serious events: 30 serious events
Other events: 55 other events
Deaths: 12 deaths
Placebo - Randomization Phase/Verdiperstat - OLE Phase
Serious events: 27 serious events
Other events: 71 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Verdiperstat - Randomization Phase
n=168 participants at risk
Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=168 participants at risk
Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/Verdiperstat - OLE Phase
n=123 participants at risk
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/Verdiperstat - OLE Phase
n=140 participants at risk
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Wound infection
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.4%
2/140 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.6%
2/123 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.4%
2/140 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Urinary tract infection
|
4.2%
7/168 • Number of events 11 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
3.3%
4/123 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Pneumonia
|
3.0%
5/168 • Number of events 5 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Urosepsis
|
2.4%
4/168 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.2%
2/168 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Pneumonia aspiration
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.2%
2/168 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.1%
3/140 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
4/168 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Sepsis
|
1.8%
3/168 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.1%
3/140 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
COVID-19
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Clostridial sepsis
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Diverticulitis
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Herpes zoster
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Infected skin ulcer
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Infection
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Localised infection
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
Pyelonephritis acute
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Multiple system atrophy
|
1.8%
3/168 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Syncope
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Bradykinesia
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Hypoaesthesia
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Loss of consciousness
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Presyncope
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Disease progression
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Fatigue
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
General physical health deterioration
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Oedema peripheral
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Pyrexia
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Sudden death
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
3/168 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.4%
2/140 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Cardiac disorders
Cardiac arrest
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.6%
2/123 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.1%
3/140 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Cardiac disorders
Pericarditis constrictive
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Renal and urinary disorders
Bladder pain
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Renal and urinary disorders
Renal pain
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Renal and urinary disorders
Urinary retention
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Vascular disorders
Arteriosclerosis
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Product Issues
Device occlusion
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Psychiatric disorders
Depression
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Dorsal ramus syndrome
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Oromandibular dystonia
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Investigations
Blood creatine phosphokinase abnormal
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Investigations
Weight decreased
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/140 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/168 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.00%
0/123 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.71%
1/140 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
Other adverse events
| Measure |
Verdiperstat - Randomization Phase
n=168 participants at risk
Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase.
|
Placebo - Randomization Phase
n=168 participants at risk
Participants received placebo matching with verdiperstat for 48 weeks.
|
Verdiperstat - Randomization Phase/Verdiperstat - OLE Phase
n=123 participants at risk
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to continue verdiperstat 600 mg orally twice daily for 48 weeks.
|
Placebo - Randomization Phase/Verdiperstat - OLE Phase
n=140 participants at risk
Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
26.2%
44/168 • Number of events 71 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
32.1%
54/168 • Number of events 77 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
21.1%
26/123 • Number of events 38 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
20.7%
29/140 • Number of events 40 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Infections and infestations
COVID-19
|
1.2%
2/168 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
6.5%
11/168 • Number of events 11 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
3.6%
5/140 • Number of events 5 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Headache
|
12.5%
21/168 • Number of events 25 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
13.7%
23/168 • Number of events 28 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
7.9%
11/140 • Number of events 12 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Dizziness
|
7.7%
13/168 • Number of events 16 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
13.1%
22/168 • Number of events 22 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
3.6%
5/140 • Number of events 6 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Balance disorder
|
10.1%
17/168 • Number of events 20 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
8.3%
14/168 • Number of events 15 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.9%
4/140 • Number of events 5 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Nervous system disorders
Syncope
|
1.8%
3/168 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.4%
9/168 • Number of events 11 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.6%
2/123 • Number of events 5 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.7%
8/140 • Number of events 8 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
22.0%
37/168 • Number of events 66 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
23.2%
39/168 • Number of events 53 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
17.1%
21/123 • Number of events 27 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
15.0%
21/140 • Number of events 38 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Fatigue
|
8.9%
15/168 • Number of events 15 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
8.3%
14/168 • Number of events 17 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
4.9%
6/123 • Number of events 6 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.9%
4/140 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Gait disturbance
|
7.1%
12/168 • Number of events 12 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
7.1%
12/168 • Number of events 12 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.6%
2/123 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.4%
2/140 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Oedema peripheral
|
7.1%
12/168 • Number of events 12 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
4.2%
7/168 • Number of events 8 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
4.9%
6/123 • Number of events 6 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.9%
4/140 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Constipation
|
11.3%
19/168 • Number of events 21 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
7.1%
12/168 • Number of events 13 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.7%
7/123 • Number of events 7 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.9%
4/140 • Number of events 6 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Gastrointestinal disorders
Nausea
|
10.1%
17/168 • Number of events 19 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
4.8%
8/168 • Number of events 8 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.7%
8/140 • Number of events 9 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
7/168 • Number of events 7 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.4%
9/168 • Number of events 10 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.1%
3/140 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
6/168 • Number of events 6 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.4%
9/168 • Number of events 9 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.4%
2/140 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Vascular disorders
Orthostatic hypotension
|
4.2%
7/168 • Number of events 7 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
6.5%
11/168 • Number of events 12 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
3.3%
4/123 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.9%
4/140 • Number of events 4 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Vascular disorders
Hypertension
|
1.8%
3/168 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.4%
9/168 • Number of events 9 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.1%
3/140 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Psychiatric disorders
Depression
|
6.0%
10/168 • Number of events 11 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
4.2%
7/168 • Number of events 7 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
3/123 • Number of events 3 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
1.4%
2/140 • Number of events 2 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
9/168 • Number of events 12 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.4%
4/168 • Number of events 5 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.81%
1/123 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
2.9%
4/140 • Number of events 5 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.4%
9/168 • Number of events 13 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
0.60%
1/168 • Number of events 1 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
4.9%
6/123 • Number of events 6 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.0%
7/140 • Number of events 7 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
|
General disorders
Asthenia
|
4.2%
7/168 • Number of events 7 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
3.6%
6/168 • Number of events 7 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
4.1%
5/123 • Number of events 5 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
5.0%
7/140 • Number of events 8 • TEAEs were reported from first dose of study drug and prior to 30 days after the last dose of study drug, maximum of 100 weeks.
Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60