Trial Outcomes & Findings for Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study) (NCT NCT05238116)
NCT ID: NCT05238116
Last Updated: 2026-04-30
Results Overview
Favorable overall response was defined as being alive and having a complete or partial overall response at Day 84 as determined by the DRC. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
85 participants
Primary outcome timeframe
At Day 84
Results posted on
2026-04-30
Participant Flow
Participant milestones
| Measure |
PC945
Participants received PC945 for 12 weeks
|
Placebo
Participants received PC945-Placebo for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
28
|
|
Overall Study
Received at Least One Dose of Study Drug
|
56
|
27
|
|
Overall Study
mITT Population
|
41
|
20
|
|
Overall Study
COMPLETED
|
23
|
15
|
|
Overall Study
NOT COMPLETED
|
34
|
13
|
Reasons for withdrawal
| Measure |
PC945
Participants received PC945 for 12 weeks
|
Placebo
Participants received PC945-Placebo for 12 weeks
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
2
|
|
Overall Study
Study Terminated
|
4
|
3
|
|
Overall Study
Death
|
16
|
7
|
|
Overall Study
Participant non-compliance
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
Baseline characteristics by cohort
| Measure |
PC945
n=56 Participants
Participants received PC945
|
Placebo
n=27 Participants
Participants received PC945-Placebo
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to <64 years
|
39 Participants
n=14 Participants
|
19 Participants
n=34 Participants
|
58 Participants
n=69 Participants
|
|
Age, Customized
65 to <84 years
|
17 Participants
n=14 Participants
|
8 Participants
n=34 Participants
|
25 Participants
n=69 Participants
|
|
Age, Customized
≥85 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=14 Participants
|
10 Participants
n=34 Participants
|
32 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=14 Participants
|
17 Participants
n=34 Participants
|
51 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=14 Participants
|
8 Participants
n=34 Participants
|
17 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=14 Participants
|
16 Participants
n=34 Participants
|
51 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
10 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
9 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=14 Participants
|
20 Participants
n=34 Participants
|
61 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
13 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: At Day 84Population: For the interim analysis, the modified intention-to-treat (mITT) population was defined as randomized participants who had DRC-confirmed refractory, proven or probable invasive pulmonary aspergillosis (IPA), and who received at least one dose of blinded study drug. Overall number of participants analyzed = participants evaluable for this outcome measure. Randomization was stratified by mortality risk (high vs low).
Favorable overall response was defined as being alive and having a complete or partial overall response at Day 84 as determined by the DRC. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
Outcome measures
| Measure |
PC945
n=41 Participants
Participants received PC945
|
Placebo
n=20 Participants
Participants received PC945-Placebo
|
|---|---|---|
|
Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)
Low Risk Participants
|
2 participants
|
3 participants
|
|
Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)
Overall
|
11 participants
|
8 participants
|
|
Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)
High Risk Participants
|
9 participants
|
5 participants
|
SECONDARY outcome
Timeframe: up to 12 weeks (Day 84)Population: For the interim analysis, the modified intention-to-treat (mITT) population was defined as randomized participants who had DRC-confirmed refractory, proven or probable IPA, and who received at least one dose of blinded study drug. Overall number of participants analyzed = participants evaluable for this outcome measure.
Favorable overall response was defined as having a complete or partial overall response at at any time during the 12-week treatment where the survival component was not included as a part of the response definition. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
Outcome measures
| Measure |
PC945
n=41 Participants
Participants received PC945
|
Placebo
n=20 Participants
Participants received PC945-Placebo
|
|---|---|---|
|
Number of Participants With Favorable Overall Response
High Risk Participants
|
12 participants
|
6 participants
|
|
Number of Participants With Favorable Overall Response
Low Risk Participants
|
3 participants
|
3 participants
|
|
Number of Participants With Favorable Overall Response
Overall
|
15 participants
|
9 participants
|
SECONDARY outcome
Timeframe: up to Day 42 or Day 84Population: For the interim analysis, the modified intention-to-treat (mITT) population was defined as randomized participants who had DRC-confirmed refractory, proven or probable IPA, and who received at least one dose of blinded study drug. Overall number of participants analyzed = participants evaluable for this outcome measure.
Time to favorable overall response was defined as the time from randomization to the first favorable overall response (complete or partial response). Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
Outcome measures
| Measure |
PC945
n=15 Participants
Participants received PC945
|
Placebo
n=9 Participants
Participants received PC945-Placebo
|
|---|---|---|
|
Time to Favorable Overall Response
Day 42
|
8 participants
|
6 participants
|
|
Time to Favorable Overall Response
Day 84
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From First Dose of Study Treatment up to Week 16 (Safety Follow-up)Population: The intent-to-treat (ITT) population comprised of all randomized subjects.
All-cause mortality was defined as death from any cause.
Outcome measures
| Measure |
PC945
n=57 Participants
Participants received PC945
|
Placebo
n=28 Participants
Participants received PC945-Placebo
|
|---|---|---|
|
All-cause Mortality
Death After Randomization
|
21 Participants
|
8 Participants
|
|
All-cause Mortality
Death Prior to Study Treatment
|
1 Participants
|
1 Participants
|
|
All-cause Mortality
Death While on Study Treatment
|
5 Participants
|
3 Participants
|
|
All-cause Mortality
Death After Study Treatment Discontinuation
|
11 Participants
|
3 Participants
|
|
All-cause Mortality
Death After Study Discontinuation
|
4 Participants
|
1 Participants
|
Adverse Events
PC945
Serious events: 36 serious events
Other events: 45 other events
Deaths: 21 deaths
Placebo
Serious events: 18 serious events
Other events: 25 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
PC945
n=56 participants at risk
Participants received PC945
|
Placebo
n=27 participants at risk
Participants received PC945-Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Cardiac disorders
Pericardial effusion
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Gastrointestinal disorders
Ascites
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Gastrointestinal disorders
Colitis
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Gastrointestinal disorders
Ileus
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
General disorders
Chest pain
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
General disorders
Death
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
General disorders
Oedema peripheral
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
General disorders
Pyrexia
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
General disorders
Systemic inflammatory response syndrome
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Immune system disorders
Acute graft versus host disease
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Immune system disorders
Anaphylactic reaction
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Immune system disorders
Graft versus host disease
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Acute sinusitis
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Bacteraemia
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
10.7%
6/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
11.1%
3/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
COVID-19
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Empyema
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Giardiasis
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Herpes simplex reactivation
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Human herpesvirus 6 encephalitis
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Pneumonia
|
5.4%
3/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Pneumonia bacterial
|
8.9%
5/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Sepsis
|
17.9%
10/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Sepsis syndrome
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Septic embolus
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Septic shock
|
5.4%
3/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
11.1%
3/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Thrombophlebitis septic
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Investigations
Blood bilirubin increased
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Investigations
Blood creatinine increased
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Investigations
Hepatic enzyme increased
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
7.1%
4/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Nervous system disorders
Headache
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Nervous system disorders
Lethargy
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Nervous system disorders
Myelitis transverse
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Psychiatric disorders
Delirium
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Psychiatric disorders
Hallucination
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.1%
4/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Vascular disorders
Hypertension
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Vascular disorders
Shock
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
0.00%
0/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
Other adverse events
| Measure |
PC945
n=56 participants at risk
Participants received PC945
|
Placebo
n=27 participants at risk
Participants received PC945-Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
6/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Gastrointestinal disorders
Constipation
|
5.4%
3/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
4/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
18.5%
5/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
4/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
3/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
General disorders
Asthenia
|
5.4%
3/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
General disorders
Pyrexia
|
12.5%
7/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
14.8%
4/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Bacteraemia
|
7.1%
4/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Parainfluenzae virus infection
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Investigations
Hepatic enzyme increased
|
5.4%
3/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
3.7%
1/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.4%
3/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
11.1%
3/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
14.8%
4/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Nervous system disorders
Headache
|
8.9%
5/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Nervous system disorders
Migraine
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
6/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
14.8%
4/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
4/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
14.8%
4/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.4%
3/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
2/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/56 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
7.4%
2/27 • From First Dose of Study up to Week 16 (Safety Follow-up)
The adverse event analysis conducted on the Safety Population defined as, all randomized participants who received at least one dose of study treatment. All-cause Mortality was conducted on the intent-to-treat (ITT) population defined as, all randomized subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has exclusive rights to the first publication via a multi-center study publication. Institutions and Investigators may publish independently only after the multi-center publication or 12 months (Sponsor's template language, for use where there is no mandated national CTA) after study completion. Independent submissions require 60 days' Sponsor review, a possible 45-day delay for IP protection, removal of confidential information, and good-faith consideration of Sponsor comments.
- Publication restrictions are in place
Restriction type: OTHER