Trial Outcomes & Findings for An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease (NCT NCT05543252)
NCT ID: NCT05543252
Last Updated: 2026-04-02
Results Overview
Change from PD0053 Baseline (screening) in mean striatum specific binding ratio (SBR) was assessed by DaT-SPECT using 123I-Ioflupane. Whole striatum was calculated as average of SBR data values for the four following "small" regions: left caudate, right caudate, left putamen, and right putamen. SBR was calculated for each region with the occipital cortex as a reference region. SBR = Average Small region minus Average Occipital region divided by Average Occipital region. Lower SBR indicated worse disease. Data were summarized by mapped visits: a DaT-SPECT within 2 months of PD0055 Screening was mapped to PD0053 Month 18; assessments after Month 23 from PD0053 Baseline were grouped as a single PD0055 EOT/ET visit.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
428 participants
Primary outcome timeframe
From Baseline (PD0053 Screening Visit) up to PD0055 end of treatment (EOT) or early termination (ET) (corresponding to a visit between PD0055 Month 6 and Month 18 inclusive), up to 36 months post PD0053 Screening
Results posted on
2026-04-02
Participant Flow
The study started to enroll participants in August 2022 and concluded in March 2025.
Participant Flow refers to the Safety Set.
Participant milestones
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 end of treatment (EOT)/early termination (ET) visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
153
|
136
|
139
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
153
|
136
|
139
|
Reasons for withdrawal
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 end of treatment (EOT)/early termination (ET) visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
18
|
0
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Consent Withdrawn by Patient (not due to AE)
|
2
|
0
|
2
|
|
Overall Study
Withdrawal of informed consent form due to AEs
|
0
|
1
|
0
|
|
Overall Study
Subjects chose to discontinue due to multiple AEs
|
1
|
0
|
0
|
|
Overall Study
Sponsor's Decision
|
132
|
135
|
132
|
Baseline Characteristics
An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
n=153 Participants
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
n=136 Participants
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
n=139 Participants
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 8.2 • n=10 Participants
|
62.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Age, Customized
18 to <65 years
|
78 Participants
n=5 Participants
|
76 Participants
n=5 Participants
|
75 Participants
n=10 Participants
|
229 Participants
n=5 Participants
|
|
Age, Customized
65 to <85 years
|
75 Participants
n=5 Participants
|
60 Participants
n=5 Participants
|
64 Participants
n=10 Participants
|
199 Participants
n=5 Participants
|
|
Age, Customized
>= 85 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
57 Participants
n=5 Participants
|
54 Participants
n=10 Participants
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
79 Participants
n=5 Participants
|
85 Participants
n=10 Participants
|
260 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
123 Participants
n=5 Participants
|
116 Participants
n=5 Participants
|
121 Participants
n=10 Participants
|
360 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
4 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
24 Participants
n=5 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=10 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
125 Participants
n=5 Participants
|
115 Participants
n=5 Participants
|
120 Participants
n=10 Participants
|
360 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (PD0053 Screening Visit) up to PD0055 end of treatment (EOT) or early termination (ET) (corresponding to a visit between PD0055 Month 6 and Month 18 inclusive), up to 36 months post PD0053 ScreeningPopulation: Full Analysis Set (FAS) included all study participants who were randomized into PD0053, who signed the informed consent form (ICF) for PD0055, who received at least a partial dose of PD0055 IMP, and had at least 1 assessment post PD0055 Baseline. This analysis set excluded participants who did not meet PD0053 key inclusion/exclusion criteria. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
Change from PD0053 Baseline (screening) in mean striatum specific binding ratio (SBR) was assessed by DaT-SPECT using 123I-Ioflupane. Whole striatum was calculated as average of SBR data values for the four following "small" regions: left caudate, right caudate, left putamen, and right putamen. SBR was calculated for each region with the occipital cortex as a reference region. SBR = Average Small region minus Average Occipital region divided by Average Occipital region. Lower SBR indicated worse disease. Data were summarized by mapped visits: a DaT-SPECT within 2 months of PD0055 Screening was mapped to PD0053 Month 18; assessments after Month 23 from PD0053 Baseline were grouped as a single PD0055 EOT/ET visit.
Outcome measures
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
n=45 Participants
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
n=46 Participants
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
n=53 Participants
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Change From Baseline in Dopamine Transporter Imaging, Measured by Single Photon Emission Computed Tomography (DaT-SPECT), Whole Striatum Specific Binding Ratio up to PD0055 EOT or ET (Corresponding to a Visit Between PD0055 Month 6 and Month 18 Inclusive)
|
-0.371 specific binding ratio
Standard Deviation 0.227
|
-0.370 specific binding ratio
Standard Deviation 0.285
|
-0.426 specific binding ratio
Standard Deviation 0.322
|
SECONDARY outcome
Timeframe: From Baseline (PD0053 Screening Visit) to PD0055 Month 18, up to 36 months post PD0053 ScreeningPopulation: FAS included all study participants who were randomized into PD0053, who signed the informed consent form (ICF) for PD0055, who received at least a partial dose of PD0055 IMP, and had at least 1 assessment post PD0055 Baseline. This analysis set excluded participants who did not meet PD0053 key inclusion/exclusion criteria. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
The Cumulative Levodopa Equivalent Daily Dose (LEDD) was calculated for each participant at each visit, based on the dose level and frequency indicated on the concomitant medication form and at the end of study. This was the sum of all the LEDDs taken up to that visit. Any changes in medication (type, dose, or dosing regimen) were accounted for when calculating cumulative doses.
Outcome measures
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
n=50 Participants
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
n=23 Participants
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
n=53 Participants
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Cumulative Levodopa Equivalent Daily Dose (LEDD) at PD0055 Month 18
|
216637.47 milligrams
Standard Deviation 168742.22
|
219553.33 milligrams
Standard Deviation 198681.91
|
201143.37 milligrams
Standard Deviation 174598.34
|
SECONDARY outcome
Timeframe: From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)Population: Safety Set (SS) included all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 investigational medicinal product (IMP).
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place.
Outcome measures
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
n=153 Participants
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
n=136 Participants
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
n=139 Participants
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
79.1 percentage of participants
|
73.5 percentage of participants
|
76.3 percentage of participants
|
SECONDARY outcome
Timeframe: From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)Population: SS included all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, and other important medical events which are based on medical or scientific judgement may jeopardise the participant's life, or may require medical or surgical intervention to prevent any of the above. The percentage of participants data was rounded to one decimal place.
Outcome measures
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
n=153 Participants
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
n=136 Participants
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
n=139 Participants
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Percentage of Participants With Serious TEAEs
|
4.6 percentage of participants
|
6.6 percentage of participants
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)Population: SS included all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
Percentage of participants with TEAEs leading to withdrawal from the study are presented. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place.
Outcome measures
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
n=153 Participants
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
n=136 Participants
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
n=139 Participants
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Percentage of Participants With TEAEs Leading to Withdrawal From the Study
|
13.7 percentage of participants
|
0.7 percentage of participants
|
2.9 percentage of participants
|
Adverse Events
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
Serious events: 7 serious events
Other events: 70 other events
Deaths: 1 deaths
Early-start Minzasolmin (UCB0599) 180 mg/Day
Serious events: 9 serious events
Other events: 56 other events
Deaths: 0 deaths
Early-start Minzasolmin (UCB0599) 360 mg/Day
Serious events: 10 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
n=153 participants at risk
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
n=136 participants at risk
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
n=139 participants at risk
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.74%
1/136 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Immune system disorders
Anaphylactic reaction
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
Pneumonia
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
Septic shock
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Investigations
Electrocardiogram abnormal
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.74%
1/136 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
1.5%
2/136 • Number of events 2 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.74%
1/136 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.74%
1/136 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
1.5%
2/136 • Number of events 2 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Psychiatric disorders
Suicide attempt
|
0.65%
1/153 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.74%
1/136 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.74%
1/136 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.72%
1/139 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.74%
1/136 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.74%
1/136 • Number of events 1 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
Other adverse events
| Measure |
Delayed-start Minzasolmin (UCB0599) 360 mg/Day
n=153 participants at risk
Participants who received placebo during Study PD0053 (NCT04658186) were administered minzasolmin (UCB0599) 180 milligrams (mg) capsules, orally, twice daily (BID), a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 180 mg/Day
n=136 participants at risk
Participants who received minzasolmin (UCB0599) 180 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 90 mg capsules, orally BID, for a total daily dose of 180 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
Early-start Minzasolmin (UCB0599) 360 mg/Day
n=139 participants at risk
Participants who received minzasolmin (UCB0599) 360 mg during Study PD0053 (NCT04658186) continued to receive minzasolmin (UCB0599) 180 mg capsules, orally, BID for a total daily dose of 360 mg, from Day 1 of PD0055 up to the early termination of the study. As a decision was made to terminate the study early, the participants were asked to complete, at a minimum, the assessments scheduled to be performed at a PD0055 EOT/ET visit.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.2%
8/153 • Number of events 8 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
6.6%
9/136 • Number of events 9 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
9.4%
13/139 • Number of events 13 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Gastrointestinal disorders
Nausea
|
6.5%
10/153 • Number of events 10 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
General disorders
Fatigue
|
5.9%
9/153 • Number of events 9 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.1%
7/136 • Number of events 7 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
10/153 • Number of events 12 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.1%
7/136 • Number of events 10 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
7.2%
10/139 • Number of events 11 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
COVID-19
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.1%
7/136 • Number of events 7 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.0%
7/139 • Number of events 7 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Infections and infestations
Influenza
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.0%
7/139 • Number of events 7 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Investigations
Alanine aminotransferase increased
|
7.8%
12/153 • Number of events 13 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
12/153 • Number of events 14 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
11.8%
16/136 • Number of events 18 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.8%
8/139 • Number of events 9 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
12/153 • Number of events 19 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
6.6%
9/136 • Number of events 9 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
10/153 • Number of events 10 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Nervous system disorders
Headache
|
7.2%
11/153 • Number of events 12 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
6.6%
9/136 • Number of events 10 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
7.2%
10/139 • Number of events 13 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.1%
7/136 • Number of events 7 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Psychiatric disorders
Depression
|
5.9%
9/153 • Number of events 9 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
8/153 • Number of events 9 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/136 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.9%
8/136 • Number of events 8 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/153 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
5.1%
7/136 • Number of events 7 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
0.00%
0/139 • From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)
A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. Safety Set (SS) consisted of all study participants who were randomized in PD0053 and who received at least a partial dose of PD0055 IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60