Trial Outcomes & Findings for A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis (NCT NCT05032066)
NCT ID: NCT05032066
Last Updated: 2025-12-03
Results Overview
FVC was assessed using a blowing device provided by the Sponsor. The best of 3 efforts was defined as the highest FVC, obtained on any of the 3 blows meeting the ATS/ERS criteria with a maximum of 8 maneuvers. FVC % predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2025-12-03
Participant Flow
A total of 153 participants with Idiopathic Pulmonary Fibrosis (IPF) were enrolled in 16 countries between January 2022 and December 2024.
This trial consisted of 2 parts. During part 1 (Core Phase) participants were randomized in 1:1:1 ratio to receive HZN-825 300 mg once daily (QD), twice daily (BID) or placebo, for 52 weeks. Part 2 (Extension Phase) was an optional, open-label extension (OLE) where all participants received HZN-825 BID for 52 weeks. 11 participants who completed part 1 did not enter the part 2.
Participant milestones
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Part 1: Core Phase
STARTED
|
49
|
52
|
52
|
|
Part 1: Core Phase
COMPLETED
|
40
|
38
|
43
|
|
Part 1: Core Phase
NOT COMPLETED
|
9
|
14
|
9
|
|
Part 2: Extension Phase
STARTED
|
36
|
34
|
40
|
|
Part 2: Extension Phase
COMPLETED
|
4
|
5
|
6
|
|
Part 2: Extension Phase
NOT COMPLETED
|
32
|
29
|
34
|
Reasons for withdrawal
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Part 1: Core Phase
Withdrawal by Subject/Guardian
|
4
|
6
|
5
|
|
Part 1: Core Phase
Physician Decision
|
0
|
1
|
1
|
|
Part 1: Core Phase
Lost to Follow-up
|
0
|
0
|
1
|
|
Part 1: Core Phase
Death
|
3
|
4
|
2
|
|
Part 1: Core Phase
Adverse Event
|
2
|
3
|
0
|
|
Part 2: Extension Phase
Withdrawal by Subject/Guardian
|
2
|
1
|
2
|
|
Part 2: Extension Phase
Study Terminated by Sponsor
|
27
|
22
|
27
|
|
Part 2: Extension Phase
Physician Decision
|
1
|
2
|
0
|
|
Part 2: Extension Phase
Death
|
2
|
4
|
5
|
Baseline Characteristics
A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
31 Participants
n=205 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=9 Participants
|
42 Participants
n=6 Participants
|
45 Participants
n=9 Participants
|
122 Participants
n=205 Participants
|
|
Age, Continuous
|
70.0 years
n=9 Participants
|
73.5 years
n=6 Participants
|
73.0 years
n=9 Participants
|
73.0 years
n=205 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
52 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=9 Participants
|
40 Participants
n=6 Participants
|
37 Participants
n=9 Participants
|
101 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
67 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=9 Participants
|
36 Participants
n=6 Participants
|
27 Participants
n=9 Participants
|
86 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
37 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=9 Participants
|
35 Participants
n=6 Participants
|
40 Participants
n=9 Participants
|
110 Participants
n=205 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
|
Forced Vital Capacity (FVC) percent (FVC %) Predicted at Baseline
|
73.23 % predicted FVC
STANDARD_DEVIATION 17.074 • n=9 Participants
|
72.11 % predicted FVC
STANDARD_DEVIATION 16.558 • n=6 Participants
|
72.66 % predicted FVC
STANDARD_DEVIATION 12.761 • n=9 Participants
|
72.66 % predicted FVC
STANDARD_DEVIATION 15.456 • n=205 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set (FAS): All participants who were randomized and took at least 1 dose of HZN-825.
FVC was assessed using a blowing device provided by the Sponsor. The best of 3 efforts was defined as the highest FVC, obtained on any of the 3 blows meeting the ATS/ERS criteria with a maximum of 8 maneuvers. FVC % predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Change in FVC % Predicted From Baseline to Week 52
|
-4.13 % predicted FVC
Standard Error 1.045
|
-3.38 % predicted FVC
Standard Error 1.092
|
-2.99 % predicted FVC
Standard Error 1.025
|
PRIMARY outcome
Timeframe: OLE baseline (Week 52) and Week 104Population: OLE Phase Analysis Set (OLE-SAF): All participants that were enrolled in OLE Phase and took at least 1 dose of HZN-825 during the OLE Phase.
OLE baseline was defined as the latest measurement prior to the first dose of HZN-825 in the extension phase. FVC was assessed using a blowing device provided by the Sponsor. The best of 3 efforts was defined as the highest FVC, obtained on any of the 3 blows meeting the ATS/ERS criteria with a maximum of 8 maneuvers. FVC % predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=4 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=3 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=5 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Extension Phase: Change in FVC % Predicted From OLE Baseline to Week 104
|
11.38 % predicted FVC
Standard Deviation 23.237
|
-0.63 % predicted FVC
Standard Deviation 16.283
|
-2.62 % predicted FVC
Standard Deviation 6.305
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: FAS: All participants who were randomized and took at least 1 dose of HZN-825.
FVC was assessed using a blowing device provided by the Sponsor. The best of 3 efforts was defined as the highest FVC, obtained on any of the 3 blows meeting the ATS/ERS criteria with a maximum of 8 maneuvers. FVC % predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Number of Participants With a Decline in FVC % Predicted ≥10% From Baseline at Week 52
|
6 participants
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: FAS: All participants who were randomized and took at least 1 dose of HZN-825.
The 6MWT measures the distance a subject can quickly walk on a flat, hard surface in 6 minutes (6-minute walk distance). This test evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units and muscle metabolism.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Change in the 6-Minute Walk Test (6MWT) Results From Baseline to Week 52
|
14.00 Meters
Standard Error 12.990
|
-3.95 Meters
Standard Error 13.081
|
-2.71 Meters
Standard Error 12.757
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: FAS: All participants who were randomized and took at least 1 dose of HZN-825.
The K-BILD is a self-completed health status questionnaire comprising 15 items and a 7-point Likert response scale that was developed and validated specifically for patients with IPF. This questionnaire has 3 domains: psychological, breathlessness and activities and chest symptoms. The K-BILD domains and total score range from 0 to 100; 100 represents best health status. A positive change from baseline indicates an improvement in symptoms.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Change in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Scores From Baseline to Week 52
|
-1.5 Score on a scale
Standard Error 1.65
|
-1.4 Score on a scale
Standard Error 1.67
|
-0.3 Score on a scale
Standard Error 1.62
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: FAS: All participants who were randomized and took at least 1 dose of HZN-825.
The L-IPF is a validated questionnaire that assesses symptoms, disease impacts and health-related quality of life in subjects with IPF. This questionnaire was developed with input from the FDA and comprises 2 modules: a 15-item symptom module with 3 domains (dyspnea, cough, and energy), all with a 24-hour recall, and a 20-item impacts module with 1-week recall. Symptoms Total Score and Impacts Total Score were transformed to a model-based scale ranging from 0 to 100 where higher scores indicate greater impairment.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Change in Living With IPF (L-IPF) Scores From Baseline to Week 52
L-IPF Symptoms Total Score
|
4.0 Score on a scale
Standard Error 1.42
|
2.6 Score on a scale
Standard Error 1.45
|
0.6 Score on a scale
Standard Error 1.39
|
|
Core Phase: Change in Living With IPF (L-IPF) Scores From Baseline to Week 52
L-IPF Impact Total Score
|
3.1 Score on a scale
Standard Error 1.93
|
1.3 Score on a scale
Standard Error 1.97
|
-0.8 Score on a scale
Standard Error 1.90
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: FAS: All participants who were randomized and took at least 1 dose of HZN-825.
The LCQ is a patient-reported questionnaire evaluating the impact of cough on quality of life. The LCQ comprises 19 items and takes 5 to 10 minutes to complete. Each item assesses symptoms or the impact of symptoms over the last 2 weeks on a 7-point Likert scale. Scores in 3 domains (physical, psychological, and social) are calculated as a mean for each domain (range: 1 to 7). A total score (range: 3 to 21) is also calculated by adding together the domain scores. Higher scores indicate better quality of life and a positive change from baseline indicates an improvement in quality of life.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Change in Leicester Cough Questionnaire (LCQ) Scores From Baseline to Week 52
|
0.19 Score on a scale
Standard Error 0.463
|
-0.45 Score on a scale
Standard Error 0.468
|
0.54 Score on a scale
Standard Error 0.453
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS: All participants who were randomized and took at least 1 dose of HZN-825, inclusive of censoring.
Hospitalization due to respiratory distress was defined as a non-elective hospitalization lasting more than 24 hours in a hospital, emergency room or observation unit, due to respiratory causes that occur after randomization Adverse events identified as leading to hospitalization due to respiratory distress were adjudicated to confirm that the event and hospitalization met the stated criteria. Participants who did not experience a hospitilization event were considered censored.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Time to First Hospitalization Due to Respiratory Distress From Baseline up to Week 52
|
NA Days
Time to event was analyzed using the Kaplan-Meier method, but the median and inter-quartile range (IQR) could not be estimated due to limited number of events at the time of analysis.
|
NA Days
Time to event was analyzed using the Kaplan-Meier method, but the median and IQR could not be estimated due to limited number of events at the time of analysis.
|
NA Days
Time to event was analyzed using the Kaplan-Meier method, but the median and IQR could not be estimated due to limited number of events at the time of analysis.
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS: All participants who were randomized and took at least 1 dose of HZN-825, inclusive of censoring.
The time-to-progression was defined as the duration from the date of first dose of study drug to either (a) the date of the visit where FVC % predicted declines ≥ 10% from Baseline or (b) the date of participant death, whichever occurred earlier. Results were given based on the Kaplan-Meier reading with a cutoff at Day 365.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Time to First Onset of the Composite Endpoint of Progression-Free Survival (PFS) From Baseline up to Week 52
|
NA Days
There was an insufficient number of participants with an event to calculate the upper limit. The results for the median and lower limit were beyond the cutoff date of Day 365.
|
NA Days
Interval 357.0 to
The results for the median and upper limit were beyond the cutoff date of Day 365.
|
NA Days
There was an insufficient number of participants with an event (7) to calculate a median and inter-quartile range.
|
SECONDARY outcome
Timeframe: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.Population: Safety analysis set: all participants who took any dose of study drug during the Core Phase.
A TEAE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A TEAE was considered a serious adverse event (SAE) if it resulted in any of the following: death; life-threatening experience; persistent or significant disability or incapacity; inpatient hospitalization or prolongation of hospitalization; congenital anomaly or birth defect; medically important event that may require medical or surgical intervention to prevent one of the outcomes listed. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to HZN-825. Orthostatic hypotension was considered an AESI. Clinically significant changes in vital signs, electrocardiograms, echocardiograms and laboratory tests recorded after treatment administration were documented as TEAEs.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
n=52 Participants
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Core Phase: TEAEs
|
38 Participants
|
42 Participants
|
38 Participants
|
|
Core Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Core Phase: SAEs
|
10 Participants
|
14 Participants
|
9 Participants
|
|
Core Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Core Phase: AESIs
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Extension Phase: TEAEs
|
27 Participants
|
22 Participants
|
33 Participants
|
|
Core Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Extension Phase: SAEs
|
8 Participants
|
6 Participants
|
9 Participants
|
|
Core Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Extension Phase: AESIs
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (2-4 hours after the first dose), Week 4 (pre-dose), Week 10, Weeks 16 and 28 (pre-dose and 2-4 hours post-dose), and Weeks 40 and 52 (pre-dose for participants entering OLE).Population: Pharmacokinetic analysis set: all randomized participants who took at least 1 dose of HZN-825 and have at least 1 nonmissing postdose concentration value reported by the PK laboratory.
Pre- and Post-dose Concentrations of HZN-825 were presented.
Outcome measures
| Measure |
HZN-825 300 mg QD Then HZN-825 300 mg BID
n=49 Participants
In the core phase participants received HZN-825 300 mg QD, for 52 weeks. In the optional OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
HZN-825 300 mg BID
n=52 Participants
In the core phase participants received HZN-825 300 mg BID, for 52 weeks. In the optional OLE phase of the study (Part 2) participants continued to receive HZN-825 BID for 52 weeks.
|
Placebo Then HZN-825 300 mg BID
In the core phase participants received Placebo for 52 weeks. In the OLE phase of the study (Part 2) participants received HZN-825 BID for 52 weeks.
|
|---|---|---|---|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Week 28 (Post-dose)
|
19410.7 ng/mL
Standard Deviation 13812.87
|
27598.4 ng/mL
Standard Deviation 13634.06
|
—
|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Day 1 (Post-dose)
|
16676.2 ng/mL
Standard Deviation 11030.30
|
16209.4 ng/mL
Standard Deviation 11592.69
|
—
|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Week 4 (Pre-dose)
|
6521.3 ng/mL
Standard Deviation 7756.18
|
18360.0 ng/mL
Standard Deviation 11953.98
|
—
|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Week 10
|
11372.8 ng/mL
Standard Deviation 11123.02
|
23807.8 ng/mL
Standard Deviation 13864.61
|
—
|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Week 16 (Pre-dose)
|
5296.4 ng/mL
Standard Deviation 3093.68
|
16889.8 ng/mL
Standard Deviation 9952.20
|
—
|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Week 16 (Post-dose)
|
21162.9 ng/mL
Standard Deviation 11543.77
|
24629.3 ng/mL
Standard Deviation 11871.17
|
—
|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Week 28 (Pre-dose)
|
5435.8 ng/mL
Standard Deviation 4125.22
|
19258.1 ng/mL
Standard Deviation 10368.10
|
—
|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Week 40 (Pre-dose)
|
8487.6 ng/mL
Standard Deviation 9209.61
|
20702.0 ng/mL
Standard Deviation 13362.76
|
—
|
|
Core Phase: Pre- and Post-dose Concentrations of HZN-825
Week 52 (Pre-dose)
|
5030.2 ng/mL
Standard Deviation 3998.99
|
17330.1 ng/mL
Standard Deviation 10638.75
|
—
|
Adverse Events
Core Phase: HZN-825 300mg QD
Serious events: 10 serious events
Other events: 23 other events
Deaths: 3 deaths
Core Phase: HZN-825 300mg BID
Serious events: 14 serious events
Other events: 33 other events
Deaths: 4 deaths
Core Phase: Placebo
Serious events: 9 serious events
Other events: 20 other events
Deaths: 2 deaths
OLE Phase: HZN-825 300mg BID
Serious events: 23 serious events
Other events: 35 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Core Phase: HZN-825 300mg QD
n=49 participants at risk
Participants received HZN-825 QD orally as two 150 mg tablets in the core phase.
|
Core Phase: HZN-825 300mg BID
n=52 participants at risk
Participants received HZN-825 BID orally as two 150 mg tablets in the core phase.
|
Core Phase: Placebo
n=52 participants at risk
Participants received matching placebo orally as tablets in the core phase.
|
OLE Phase: HZN-825 300mg BID
n=110 participants at risk
All participants who received HZN-825 BID orally as two 150 mg tablets in the OLE Phase.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Right ventricular failure
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal artery thrombosis
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.6%
4/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia viral
|
4.1%
2/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.8%
2/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.1%
2/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.8%
2/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.5%
6/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.1%
2/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
4.5%
5/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Core Phase: HZN-825 300mg QD
n=49 participants at risk
Participants received HZN-825 QD orally as two 150 mg tablets in the core phase.
|
Core Phase: HZN-825 300mg BID
n=52 participants at risk
Participants received HZN-825 BID orally as two 150 mg tablets in the core phase.
|
Core Phase: Placebo
n=52 participants at risk
Participants received matching placebo orally as tablets in the core phase.
|
OLE Phase: HZN-825 300mg BID
n=110 participants at risk
All participants who received HZN-825 BID orally as two 150 mg tablets in the OLE Phase.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.2%
5/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.6%
5/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.7%
3/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.1%
3/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
8.2%
4/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.8%
2/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.4%
7/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
4/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
4/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.4%
7/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
4/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
3/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
13.5%
7/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.8%
2/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
12.2%
6/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.8%
2/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.4%
7/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
4/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.7%
3/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.8%
2/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
4/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.7%
3/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.7%
3/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.8%
2/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
5/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.6%
5/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.6%
4/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
3/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
4/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.8%
2/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.8%
2/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
2.0%
1/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.8%
2/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
4/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.6%
4/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
2/49 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.8%
3/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.9%
1/52 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.91%
1/110 • Death: From randomization to end of study (EOS), Median (min, max) was 17.7 (0.1, 25.9) months. TEAE: From 1st dose to last dose + 28 days, Median (min, max) duration was 12.0 (1.0, 13.1) months for Core Phase and 7.0 (1.6, 13.2) months for OLE Phase.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER