Trial Outcomes & Findings for GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (NCT NCT02525861)
NCT ID: NCT02525861
Last Updated: 2021-10-14
Results Overview
An Adverse Events (AEs) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Any AE that occurs on or after the first dose of IP infusion will be considered a TEAE. A TEAE that is considered potentially related to the presence of protein aggregates (particle load) in the GLASSIA solution is defined as any embolic or thrombotic event. Number of participants with TEAEs potentially related to the presence of protein aggregates (particle load) in the GLASSIA solution were reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
From start of study treatment up to Week 26
Results posted on
2021-10-14
Participant Flow
The study was conducted at 21 centers in the United States and 1 center in Canada between 08 Mar 2016 (first participant first visit) and 29 Jul 2020 (last participant last visit).
A total of 34 participants were randomized and received the study treatment.
Participant milestones
| Measure |
Cohort I: GLASSIA (High-end)
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort I: GLASSIA (High-end)
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
Baseline characteristics by cohort
| Measure |
Cohort I: GLASSIA (High-end)
n=18 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=16 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 Years
STANDARD_DEVIATION 8.95 • n=93 Participants
|
58.9 Years
STANDARD_DEVIATION 9.32 • n=4 Participants
|
58.4 Years
STANDARD_DEVIATION 9.00 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to Week 26Population: Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures.
An Adverse Events (AEs) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Any AE that occurs on or after the first dose of IP infusion will be considered a TEAE. A TEAE that is considered potentially related to the presence of protein aggregates (particle load) in the GLASSIA solution is defined as any embolic or thrombotic event. Number of participants with TEAEs potentially related to the presence of protein aggregates (particle load) in the GLASSIA solution were reported.
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=18 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=16 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to 24 hours post infusionPopulation: Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures.
An Treatment-emergent AR and suspected AR was any TEAE which met any of the following criteria: a; A TEAE that began during infusion or within 24 hours (or 1 day where time of onset is not available) following the end of IP infusion, or b; A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or c; A TEAE for which causality assessment was missing or indeterminate. Number of participants with both treatment-emergent ARs plus suspected ARs were collectively reported.
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=18 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=16 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 24 Hours Following the End of IP Infusion
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to 72 hours post infusionPopulation: Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures.
An Treatment-emergent AR and suspected AR was any TEAE which met any of the following criteria: a; A TEAE that began during infusion or within 72 hours (or 3 days where time of onset is not available) following the end of IP infusion, or b; A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or c; A TEAE for which causality assessment was missing or indeterminate. Number of participants with both treatment-emergent ARs plus suspected ARs were collectively reported.
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=18 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=16 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion
|
10 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to Week 26Population: Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures.
An AE was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Infusions may be interrupted or discontinued in an individual participant in the event of intolerable moderate to severe infusion-related AEs and/or at the discretion of the investigator. Number of infusions that are discontinued, slowed, or interrupted due to TEAEs were reported.
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=18 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=16 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs
Number of Infusions Discontinued due to TEAEs
|
0 Number of Infusions
|
0 Number of Infusions
|
|
Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs
Number of Infusions Slowed due to TEAEs
|
1 Number of Infusions
|
0 Number of Infusions
|
|
Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs
Number of Infusions Interrupted due to TEAEs
|
0 Number of Infusions
|
0 Number of Infusions
|
PRIMARY outcome
Timeframe: From start of study treatment up to Week 26Population: Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. Here, number analyzed signifies participants who were evaluable for this outcome measure at specific category.
Development of Binding/Neutralizing Anti-A1PI Antibodies=Negative or missing at Baseline and confirmed positive at any post-infusion time point. Participants that had a positive result at Baseline and missing at all post-infusion time points were included as "No Development". Neutralizing anti-A1PI antibodies were only assessed in case of positive binding anti-A1PI antibodies. Anti-A1PI antibodies was detected using validated binding and neutralizing anti-A1PI antibody assays at a qualified immunoassay laboratory. Number of participants who developed binding and/or neutralizing anti-A1PI antibodies were reported.
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=18 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=16 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Number of Participants Who Developed Binding and/or Neutralizing Anti- Alpha1-Proteinase Inhibitor(A1PI) Antibodies
Number of participants with binding Anti-A1PI antibodies
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Developed Binding and/or Neutralizing Anti- Alpha1-Proteinase Inhibitor(A1PI) Antibodies
Number of participants with neutralizing Anti-A1PI antibodies
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 14Population: BAL analysis set included a subset of the full analysis set (FAS). FAS included all enrolled participants who received at least 1 IP infusion and have at least 1 available antigenic or functional A1PI measurement (either from plasma or from ELF) during the treatment period.
Change from baseline in antigenic A1PI levels in ELF up to Week 14 was reported. Bronchoalveolar Lavage (BAL) procedures were performed at baseline and on-treatment BAL visit during GLASSIA augmentation therapy. Data for this outcome measure was analyzed and planned to be reported based on overall arm (Arms/Groups were combined as pre-specified in the study protocol).
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=16 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Change From Baseline in Antigenic Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid (ELF)
|
0.515 Micromolar (mcM)
Interval 0.08 to 2.41
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Week 14Population: BAL analysis set included a subset of the FAS. FAS included all enrolled participants who received at least 1 IP infusion and have at least 1 available antigenic or functional A1PI measurement (either from plasma or from ELF) during the treatment period.
Change from baseline in functional A1PI (also known as Anti-Neutrophil Elastase Capacity \[ANEC\]) levels in ELF up to Week 14 was reported. BAL procedures were performed at baseline and on-treatment BAL visit during GLASSIA augmentation therapy. Data for this outcome measure was analyzed and planned to be reported based on overall arm (Arms/Groups were combined as pre-specified in the study protocol).
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=16 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Change From Baseline in Functional Alpha1-Proteinase Inhibitor(A1PI) Levels in Epithelial Lining Fluid (ELF)
|
0.256 mcM
Interval -0.28 to 1.54
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to Week 26Population: Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures.
An AEs was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Any AE that occurs on or after the first dose of IP infusion will be considered a TEAE.
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=18 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=16 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 13, 25 and 26Population: Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for at specific time point.
Clinical laboratory values included Hematology (hemoglobin, leukocytes, neutrophils, reticulocytes/erythrocytes \[Ret/Ery\], platelets); Chemistry (sodium, potassium, albumin, alanine aminotransferase \[AA\], aspartate aminotransferase \[ASA\], alkaline phosphatase \[AP\], lactate dehydrogenase \[LD\], gamma glutamyl transferase \[GGT\], bilirubin, direct bilirubin \[DB\], creatinine, creatine kinase \[CK\], glucose); Urinalysis (erythrocytes urine \[EU\], protein urine \[PU\], specific gravity \[SG\], pH) and Immunology (Complement C3, Complement C4). Assessment if a value was normal, clinically non-significant abnormal, or clinically significant abnormal was done by the investigator. Number of participants who experienced a shift from normal or clinically non-significant (NCS) abnormal laboratory values at baseline \[BL\] to clinically significant (CS) abnormal laboratory values at Week 13, 25 and 26 were reported.
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=17 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=15 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Potassium: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
ASA: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
ASA: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AP: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AP: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AP: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AP: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AP: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AP: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
LD: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
LD: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
LD: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
LD: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
LD: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
LD: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
GGT: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
GGT: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
GGT: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
GGT: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
GGT: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
GGT: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Bilirubin: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Bilirubin: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Bilirubin: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Bilirubin: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Bilirubin: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Bilirubin: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
DB: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
DB: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
DB: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
DB: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
DB: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
DB: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Creatinine: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Creatinine: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Creatinine: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Creatinine: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Creatinine: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Creatinine: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
CK: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
CK: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
CK: Normal at BL→Abnormal-CS at Week 25
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
CK: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
CK: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
CK: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Glucose: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Glucose: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Glucose: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Glucose: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Glucose: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Hemoglobin: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Hemoglobin: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Hemoglobin: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Hemoglobin: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Hemoglobin: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Hemoglobin: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Leukocytes: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Leukocytes: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Leukocytes: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Leukocytes: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Leukocytes: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Leukocytes: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Neutrophils: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Neutrophils: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Neutrophils: Normal at BL→Abnormal-CS at Week 25
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Neutrophils: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Neutrophils: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Neutrophils: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Ret/Ery: Normal at BL→Abnormal-CS at Week 13
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Ret/Ery: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Ret/Ery: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Ret/Ery: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Ret/Ery: Normal at BL→Abnormal-CS at Week 26
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Ret/Ery: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Platelets: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Platelets: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Platelets: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Platelets: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Platelets: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Platelets: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Sodium: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Sodium: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Sodium: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Sodium: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Sodium: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Sodium: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Potassium: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Potassium: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Potassium: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Potassium: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Potassium: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Albumin: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Albumin: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Albumin: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Albumin: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Albumin: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Albumin: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AA: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AA: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AA: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AA: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AA: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
AA: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
ASA: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
ASA: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
ASA: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
ASA: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
PU: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
PU: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
PU: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
SG: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
SG: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
SG: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
Glucose: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
EU: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
SG: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
SG: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
EU: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
EU: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
EU: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
PU: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
PU: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
PU: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
SG: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
pH: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
pH: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
pH: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
pH: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
pH: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
pH: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C3: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C3: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C3: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C3: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C3: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C3: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C4: Normal at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C4: Abnormal-NCS at BL→Abnormal-CS at Week 13
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C4: Normal at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C4: Abnormal-NCS at BL→Abnormal-CS at Week 25
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C4: Normal at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26
C4: Abnormal-NCS at BL→Abnormal-CS at Week 26
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to Week 26Population: Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at specific category.
Viral testing for B19V consisted of viral serology or NAT for B19V (Parvovirus B19 IgG Antibody, Parvovirus B19 IgM Antibody, Parvovirus B19 DNA Quant real-time polymerase chain reaction \[RT-PCR\]). Number of participants with treatment-emergent seroconversion or positive NAT for B19V were reported.
Outcome measures
| Measure |
Cohort I: GLASSIA (High-end)
n=18 Participants
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within the normal range) at 60 milligrams per kilogram (mg/kg) body weight (BW) active Alpha1-Proteinase Inhibitor (A1PI) protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
Cohort II: GLASSIA (Low-end)
n=16 Participants
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Seroconversion or Positive Nucleic Acid Test (NAT) for Parvovirus B19 (B19V)
Number of participants with parvovirus B19 IgG antibody
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Seroconversion or Positive Nucleic Acid Test (NAT) for Parvovirus B19 (B19V)
Number of participants with parvovirus B19 IgM antibody
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Seroconversion or Positive Nucleic Acid Test (NAT) for Parvovirus B19 (B19V)
Number of participants with Parvovirus B19 DNA Quant RT-PCR
|
0 Participants
|
0 Participants
|
Adverse Events
GLASSIA (High-end)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
GLASSIA (Low-end)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GLASSIA (High-end)
n=18 participants at risk
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within) at 60 milligrams per kilogram (mg/kg) body weight (BW) active A1PI protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
GLASSIA (Low-end)
n=16 participants at risk
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Infections and infestations
Influenza
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
Other adverse events
| Measure |
GLASSIA (High-end)
n=18 participants at risk
Participants received weekly intravenous (IV) infusions of GLASSIA (lot with particle loads representing the high end within) at 60 milligrams per kilogram (mg/kg) body weight (BW) active A1PI protein at a rate of 0.2 milliliters per kilogram per minute (ml/kg/min) for 25 weeks (25 planned infusions).
|
GLASSIA (Low-end)
n=16 participants at risk
Participants received weekly IV infusions of GLASSIA (lot with particle loads representing the low end within the normal range) at 60 mg/kg BW active A1PI protein at a rate of 0.2 ml/kg/min for 25 weeks (25 planned infusions).
|
|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
3/18 • Number of events 3 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 2 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
General disorders
Influenza like illness
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Infections and infestations
Body tinea
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Infections and infestations
Ear infection
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Infections and infestations
Fungal infection
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Infections and infestations
Lower respiratory tract infection
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Infections and infestations
Nasopharyngitis
|
27.8%
5/18 • Number of events 6 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 2 • From start of study treatment up to Week 26
|
|
Infections and infestations
Rhinitis
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18 • From start of study treatment up to Week 26
|
12.5%
2/16 • Number of events 2 • From start of study treatment up to Week 26
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • From start of study treatment up to Week 26
|
18.8%
3/16 • Number of events 4 • From start of study treatment up to Week 26
|
|
Infections and infestations
Viral infection
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Investigations
Blood bicarbonate decreased
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Investigations
Oxygen saturation decreased
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Number of events 2 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 2 • From start of study treatment up to Week 26
|
|
Nervous system disorders
Lethargy
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Nervous system disorders
Sciatica
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Renal and urinary disorders
Polyuria
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18 • Number of events 2 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
2/18 • Number of events 2 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
2/18 • Number of events 2 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.6%
1/18 • Number of events 1 • From start of study treatment up to Week 26
|
0.00%
0/16 • From start of study treatment up to Week 26
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/18 • From start of study treatment up to Week 26
|
6.2%
1/16 • Number of events 1 • From start of study treatment up to Week 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER