Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Upadacitinib, ABT-494, RINVOQ
Brief summary
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed. Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.
Interventions
DRUGUpadacitinib
Upadacitinib will be administered oral as tablet
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria. * Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.
Exclusion criteria
* Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions. * Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days). | Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib. |
| Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days). | Treatment-emergent adverse events were monitored throughout the study to identify any adverse events of special interest that may indicate a trend or risk to participants. AESIs are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Study M16-046 for the UPA/UPA arm or Study M19-850 for the DUPI/UPA arm through 30 days following the last dose of upadacitinib. |
| Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | From Baseline to 30 days following last dose of study drug (Week 52) | Clinical laboratory test values are considered PCI if they meet either the lower-limit or higher-limit PCI criteria defined in the categories below. Percentage of participants with PCI laboratory values are summarized for hematology and chemistry. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. xULN = Times upper limit of the normal range. |
| Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | From Baseline to 30 days following last dose of study drug (Week 52) | PCI post-baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting\], pulse rate \[sitting\], and weight. Only those categories where at least 1 person had a non-PCI value at Baseline and met the PCI criterion at least once during post-baseline are reported. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. |
Countries
Australia, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
A total of 475 participants were enrolled at 114 sites located in 22 countries (Australia, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Taiwan, Ukraine, United Kingdom, and the US).
Pre-assignment details
Participants originally randomized to upadacitinib or dupilumab in Lead-In Study M16-046 and continued on into this Long-Term Extension Study M19-850. The ITT Population consists of all enrolled participants who received at least 1 dose of study drug in this study and is used for all efficacy analyses. The Safety Population is the same as the ITT Population and is used for all safety analyses.
Participants by arm
| Arm | Count |
|---|---|
| DUPI 300mg to UPA 30mg All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group. | 239 |
| UPA 30mg to UPA 30mg All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group. | 236 |
| Total | 475 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 11 |
| Overall Study | Lack of Efficacy | 2 | 10 |
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Other | 5 | 4 |
| Overall Study | Withdrawal by Subject | 9 | 10 |
Baseline characteristics
| Characteristic | UPA 30mg to UPA 30mg | DUPI 300mg to UPA 30mg | Total |
|---|---|---|---|
| Age, Continuous | 36.1 years STANDARD_DEVIATION 14.41 | 35.3 years STANDARD_DEVIATION 12.9 | 35.7 years STANDARD_DEVIATION 13.66 |
| Age, Customized Not Specified ≥ 40 to < 65 years | 70 Participants | 66 Participants | 136 Participants |
| Age, Customized Not Specified < 40 years | 156 Participants | 167 Participants | 323 Participants |
| Age, Customized Not Specified ≥ 65 years | 10 Participants | 6 Participants | 16 Participants |
| Duration Since AD Diagnosis | 23.938 years STANDARD_DEVIATION 14.9433 | 25.141 years STANDARD_DEVIATION 13.6369 | 24.543 years STANDARD_DEVIATION 14.2985 |
| Eczema Area and Severity Index (EASI) Score | 2.51 score on a scale STANDARD_DEVIATION 4.274 | 3.26 score on a scale STANDARD_DEVIATION 4.172 | 2.89 score on a scale STANDARD_DEVIATION 4.236 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 17 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 220 Participants | 222 Participants | 442 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 46 Participants | 49 Participants | 95 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 11 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 170 Participants | 172 Participants | 342 Participants |
| Sex: Female, Male Female | 104 Participants | 100 Participants | 204 Participants |
| Sex: Female, Male Male | 132 Participants | 139 Participants | 271 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 236 | 0 / 239 | 1 / 475 |
| other Total, other adverse events | 154 / 236 | 149 / 239 | 303 / 475 |
| serious Total, serious adverse events | 13 / 236 | 14 / 239 | 27 / 475 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib.
Time frame: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).
Population: The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events | Any TEAE | 205 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events | TESAE | 14 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events | TEAE leading to discontinuation of study drug | 12 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events | Any TEAE | 223 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events | TESAE | 17 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events | TEAE leading to discontinuation of study drug | 18 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Treatment-emergent adverse events were monitored throughout the study to identify any adverse events of special interest that may indicate a trend or risk to participants. AESIs are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Study M16-046 for the UPA/UPA arm or Study M19-850 for the DUPI/UPA arm through 30 days following the last dose of upadacitinib.
Time frame: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).
Population: The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Opportunistic infection excluding Tuberculosis and Herpes Zoster | 6 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Neutropenia | 10 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Lymphoma | 0 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Lymphopenia | 4 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Non-melanoma skin cancer (NMSC) | 0 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Herpes zoster | 26 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Hepatic disorder | 19 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Creatine phosphokinase (CPK) elevation | 31 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Malignancy | 1 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Renal dysfunction | 0 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Adjudicated gastrointestinal perforations | 0 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Active tuberculosis | 0 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Malignancy excluding NMSC | 1 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Adjudicated MACE | 0 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Anemia | 7 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Adjudicated VTE | 0 Participants |
| DUPI 300mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Serious infections | 7 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Adjudicated VTE | 0 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Serious infections | 8 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Opportunistic infection excluding Tuberculosis and Herpes Zoster | 4 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Malignancy | 0 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Non-melanoma skin cancer (NMSC) | 0 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Malignancy excluding NMSC | 0 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Lymphoma | 0 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Hepatic disorder | 15 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Adjudicated gastrointestinal perforations | 0 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Anemia | 8 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Neutropenia | 8 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Lymphopenia | 5 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Herpes zoster | 25 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Creatine phosphokinase (CPK) elevation | 44 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Renal dysfunction | 0 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Active tuberculosis | 1 Participants |
| UPA 30mg to UPA 30mg | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) | Adjudicated MACE | 0 Participants |
Primary
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Clinical laboratory test values are considered PCI if they meet either the lower-limit or higher-limit PCI criteria defined in the categories below. Percentage of participants with PCI laboratory values are summarized for hematology and chemistry. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. xULN = Times upper limit of the normal range.
Time frame: From Baseline to 30 days following last dose of study drug (Week 52)
Population: The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (U/L): Grade 3 or above | 0.4 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Hemoglobin (G/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Platelets (10^9/L): Grade 3 (25-<50) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Platelets (10^9/L): Grade 4 (<25) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Platelets (10^9/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Leukocytes (10^9/L): Grade 3 (1.0-<2.0) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Leukocytes (10^9/L): Grade 4 (<1.0) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Leukocytes (10^9/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Neutrophils(10^9/L): Grade 3 (0.5-<1.0) | 2.5 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Neutrophils(10^9/L): Grade 4 (<0.5) | 0.4 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Neutrophils(10^9/L): Grade 3 or above | 2.9 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Lymphocytes(10^9/L): Grade 3 (0.2-<0.5) | 0.8 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Lymphocytes(10^9/L): Grade 4 (<0.2) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Lymphocytes(10^9/L): Grade 3 or above | 0.8 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (U/L): Grade 3 (>5.0-20.0 xULN) | 0.4 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (U/L): Grade 4 (>20.0 xULN) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Hemoglobin (G/L): Grade 3 (<80) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (U/L): Grade 3 (>5.0-20.0 xULN) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (U/L): Grade 4 (>20.0 xULN) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (U/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alkaline Phosphatase (U/L): Grade 3 (>5.0-20.0 xULN) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alkaline Phosphatase (U/L): Grade 4 (>20.0 xULN) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alkaline Phosphatase (U/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): Grade 3 (>5.0-10.0 xULN) | 4.2 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): Grade 4 (>10.0 xULN) | 3.8 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): Grade 3 or above | 8.0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatinine (UMOL/L): Grade 3 (>3.0-6.0 xULN OR >3.0 xBaseline) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatinine (UMOL/L): Grade 4 (>6.0 xULN) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatinine (UMOL/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Phosphate (MMOL/L): Grade 3 (0.3-<0.6) | 1.7 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Phosphate (MMOL/L): Grade 4 (<0.3) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Phosphate (MMOL/L): Grade 3 or above | 1.7 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hyper (MMOL/L): Grade 3 (>3.1-3.4) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hyper (MMOL/L): Grade 4 (>3.4) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hyper (MMOL/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hypo (MMOL/L): Grade 3 (1.5-<1.75) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hypo (MMOL/L): Grade 4 (<1.5) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hypo (MMOL/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hyper (MMOL/L): Grade 3 (>155-160) | 0.5 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hyper (MMOL/L): Grade 4 (>160) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hyper (MMOL/L): Grade 3 or above | 0.5 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hypo (MMOL/L): Grade 3 (120-<130) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hypo (MMOL/L): Grade 4 (<120) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hypo (MMOL/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hyper (MMOL/L): Grade 3 (>6.0-7.0) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hyper (MMOL/L): Grade 4 (>7.0) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hyper (MMOL/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hypo (MMOL/L): Grade 3 (2.5-<3.0) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hypo (MMOL/L): Grade 4 (<2.5) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hypo (MMOL/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hyper (MMOL/L): Grade 3 (>13.9-27.8) | 1.3 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hyper (MMOL/L): Grade 4 (>27.8) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hyper (MMOL/L): Grade 3 or above | 1.3 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hypo (MMOL/L): Grade 3 (1.7-<2.2) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hypo (MMOL/L): Grade 4 (<1.7) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hypo (MMOL/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Albumin (G/L): Grade 3 (<20) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Albumin (G/L): Grade 3 or above | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Cholesterol (MMOL/L): Grade 3 (10.34<-12.92) | 1.3 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Cholesterol (MMOL/L): Grade 4 (>12.92) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Cholesterol (MMOL/L): Grade 3 or above | 1.3 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Triglycerides (MMOL/L): Grade 3 (>5.7-11.4) | 3.4 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Triglycerides (MMOL/L): Grade 4 (>11.4) | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Triglycerides (MMOL/L): Grade 3 or above | 3.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Triglycerides (MMOL/L): Grade 3 or above | 5.1 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Hemoglobin (G/L): Grade 3 (<80) | 0.8 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hyper (MMOL/L): Grade 3 (>3.1-3.4) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Hemoglobin (G/L): Grade 3 or above | 0.8 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hypo (MMOL/L): Grade 4 (<2.5) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Platelets (10^9/L): Grade 3 (25-<50) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hyper (MMOL/L): Grade 4 (>3.4) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Platelets (10^9/L): Grade 4 (<25) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Albumin (G/L): Grade 3 (<20) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Platelets (10^9/L): Grade 3 or above | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hyper (MMOL/L): Grade 3 or above | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Leukocytes (10^9/L): Grade 3 (1.0-<2.0) | 1.3 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hypo (MMOL/L): Grade 3 or above | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Leukocytes (10^9/L): Grade 4 (<1.0) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hypo (MMOL/L): Grade 3 (1.5-<1.75) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Leukocytes (10^9/L): Grade 3 or above | 1.3 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Cholesterol (MMOL/L): Grade 3 or above | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Neutrophils(10^9/L): Grade 3 (0.5-<1.0) | 3.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hypo (MMOL/L): Grade 4 (<1.5) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Neutrophils(10^9/L): Grade 4 (<0.5) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hyper (MMOL/L): Grade 3 (>13.9-27.8) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Neutrophils(10^9/L): Grade 3 or above | 3.8 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Calcium Hypo (MMOL/L): Grade 3 or above | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Lymphocytes(10^9/L): Grade 3 (0.2-<0.5) | 3.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Albumin (G/L): Grade 3 or above | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Lymphocytes(10^9/L): Grade 4 (<0.2) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hyper (MMOL/L): Grade 3 (>155-160) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Lymphocytes(10^9/L): Grade 3 or above | 3.8 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hyper (MMOL/L): Grade 4 (>27.8) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (U/L): Grade 3 (>5.0-20.0 xULN) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hyper (MMOL/L): Grade 4 (>160) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (U/L): Grade 4 (>20.0 xULN) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Triglycerides (MMOL/L): Grade 4 (>11.4) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (U/L): Grade 3 or above | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hyper (MMOL/L): Grade 3 or above | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (U/L): Grade 3 (>5.0-20.0 xULN) | 1.3 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hyper (MMOL/L): Grade 3 or above | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (U/L): Grade 4 (>20.0 xULN) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hypo (MMOL/L): Grade 3 (120-<130) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (U/L): Grade 3 or above | 1.3 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Cholesterol (MMOL/L): Grade 3 (10.34<-12.92) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alkaline Phosphatase (U/L): Grade 3 (>5.0-20.0 xULN) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hypo (MMOL/L): Grade 4 (<120) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alkaline Phosphatase (U/L): Grade 4 (>20.0 xULN) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hypo (MMOL/L): Grade 3 (1.7-<2.2) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Alkaline Phosphatase (U/L): Grade 3 or above | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Sodium Hypo (MMOL/L): Grade 3 or above | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): Grade 3 (>5.0-10.0 xULN) | 8.1 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Triglycerides (MMOL/L): Grade 3 (>5.7-11.4) | 5.1 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): Grade 4 (>10.0 xULN) | 5.1 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hyper (MMOL/L): Grade 3 (>6.0-7.0) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): Grade 3 or above | 13.1 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hypo (MMOL/L): Grade 4 (<1.7) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatinine (UMOL/L): Grade 3 (>3.0-6.0 xULN OR >3.0 xBaseline) | 0.8 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hyper (MMOL/L): Grade 4 (>7.0) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatinine (UMOL/L): Grade 4 (>6.0 xULN) | 0.4 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Cholesterol (MMOL/L): Grade 4 (>12.92) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Creatinine (UMOL/L): Grade 3 or above | 1.3 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hyper (MMOL/L): Grade 3 or above | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Phosphate (MMOL/L): Grade 3 (0.3-<0.6) | 1.3 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Glucose Hypo (MMOL/L): Grade 3 or above | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Phosphate (MMOL/L): Grade 4 (<0.3) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Potassium Hypo (MMOL/L): Grade 3 (2.5-<3.0) | 0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator | Phosphate (MMOL/L): Grade 3 or above | 1.3 percentage of participants |
Primary
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
PCI post-baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting\], pulse rate \[sitting\], and weight. Only those categories where at least 1 person had a non-PCI value at Baseline and met the PCI criterion at least once during post-baseline are reported. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline.
Time frame: From Baseline to 30 days following last dose of study drug (Week 52)
Population: The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Systolic Blood Pressure (MMHG): ≤90 and ≥20 Decrease | 0.4 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Systolic Blood Pressure (MMHG): ≥160 and ≥20 Increase | 2.5 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Diastolic Blood Pressure (MMHG): ≤50 and ≥10 Decrease | 0.4 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Diastolic Blood Pressure (MMHG): ≥100 and ≥10 Increase | 2.1 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Pulse Rate (BEATS/MIN): ≤50 and ≥15 Decrease | 1.7 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Pulse Rate (BEATS/MIN): ≥120 and ≥15 Increase | 0 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Weight (KG): >7% Decrease | 5.5 percentage of participants |
| DUPI 300mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Weight (KG): >7% Increase | 22.5 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Weight (KG): >7% Increase | 39.0 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Systolic Blood Pressure (MMHG): ≤90 and ≥20 Decrease | 0.8 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Pulse Rate (BEATS/MIN): ≤50 and ≥15 Decrease | 4.7 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Systolic Blood Pressure (MMHG): ≥160 and ≥20 Increase | 5.5 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Weight (KG): >7% Decrease | 7.6 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Diastolic Blood Pressure (MMHG): ≤50 and ≥10 Decrease | 1.3 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Pulse Rate (BEATS/MIN): ≥120 and ≥15 Increase | 2.1 percentage of participants |
| UPA 30mg to UPA 30mg | Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator | Sitting Diastolic Blood Pressure (MMHG): ≥100 and ≥10 Increase | 9.3 percentage of participants |