Trial Outcomes & Findings for To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer (NCT NCT01284348)
NCT ID: NCT01284348
Last Updated: 2024-08-29
Results Overview
A hematopoietic response was defined as an increase in a participant's hemoglobin (Hgb) of ≥1.0 g/dL above the study baseline value for 4 consecutive weeks, in the absence of red blood cell transfusion and/or erythropoiesis-stimulating agents.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to Day 28
Results posted on
2024-08-29
Participant Flow
Participant milestones
| Measure |
Sotatercept 15 mg
Participants received sotatercept 15 mg by subcutaneous (SC) injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
Treated
|
14
|
11
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Sotatercept 15 mg
Participants received sotatercept 15 mg by subcutaneous (SC) injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrew consent
|
0
|
1
|
|
Overall Study
Status not recorded
|
9
|
10
|
Baseline Characteristics
To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Sotatercept 15 mg
n=14 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=12 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
68.5 Years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
64.7 Years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: All participants who received at least 1 dose of study drug
A hematopoietic response was defined as an increase in a participant's hemoglobin (Hgb) of ≥1.0 g/dL above the study baseline value for 4 consecutive weeks, in the absence of red blood cell transfusion and/or erythropoiesis-stimulating agents.
Outcome measures
| Measure |
Sotatercept 15 mg
n=14 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=11 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Number of Participants Who Experienced a Hematopoietic Response
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: All participants who received at least 1 dose of study drug
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
Sotatercept 15 mg
n=14 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=11 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events (AEs)
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: TTP was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
TTP was defined as the time from date of randomization to date of diagnosis of progressive disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: PFS was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
PFS was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: OS was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
OS was defined as the time between randomization and death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: ORR was to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
Overall Response was defined as the percentage of participants who achieved an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 guidelines. CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Quality of Life parameters were to be analyzed in Part 2 of the study. Due to low enrollment, the study was terminated early and Part 2 was not performed.
Participants were to be assessed on improvement of quality of life using the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4.0) and the Lung Cancer Symptom Scale (LCSS). The FACIT Fatigue score ranges from 0 to 52, with 0 representing the best outcome and 52 representing the worst outcome. The LCSS is a 9-item patient-rated scale, 6 of which measure major symptoms (loss of appetite, fatigue, cough, dyspnoea, pain, and haemoptysis), and 3 of which are summation items related to total symptomatic distress, activity, and overall quality of life. Participants responses are measured using the mean score on the 9-item visual analogue scales, with 100-mm lines, with 0 representing the best outcome and 100 representing the worst outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 28Population: All participants who received at least 1 dose of study treatment and had data for AUC0-28d of Sotatercept Following a Single Dose
AUC0-28d is a measure of the mean concentration levels of a drug in the plasma from time 0 to 28 days.
Outcome measures
| Measure |
Sotatercept 15 mg
n=13 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=7 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to 28 Days (AUC0-28d) of Sotatercept Following a Single Dose
|
24443.28 day*ng/mL
Standard Deviation 8130.52
|
43977.03 day*ng/mL
Standard Deviation 18490.17
|
SECONDARY outcome
Timeframe: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43Population: All participants who received at least 1 dose of study treatment and had data for AUC0-inf of Sotatercept Following a Single Dose
AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
Outcome measures
| Measure |
Sotatercept 15 mg
n=10 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=3 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Sotatercept Following a Single Dose
|
40145.34 day*ng/mL
Standard Deviation 20680.76
|
137994.6 day*ng/mL
Standard Deviation 18183.66
|
SECONDARY outcome
Timeframe: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43Population: All participants who received at least 1 dose of study treatment and had data for Cmax of Sotatercept Following a Single Dose
Cmax is a measure of the maximum amount of drug in the plasma after a dose is given.
Outcome measures
| Measure |
Sotatercept 15 mg
n=14 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=9 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Sotatercept Following a Single Dose
|
1325.33 ng/mL
Standard Deviation 435.89
|
2069.68 ng/mL
Standard Deviation 842.43
|
SECONDARY outcome
Timeframe: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43Population: All participants who received at least 1 dose of study treatment and had data for Tmax of Sotatercept Following a Single Dose of Sotatercept
Tmax is a measure of the time it takes for a drug to reach maximum concentration in the plasma after the dose is given.
Outcome measures
| Measure |
Sotatercept 15 mg
n=14 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=9 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Time to Maximum Concetration (Tmax) of Sotatercept Following a Single Dose
|
8.16 Days
Standard Deviation 3.78
|
12.31 Days
Standard Deviation 7.67
|
SECONDARY outcome
Timeframe: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43Population: All participants who received at least 1 dose of study treatment and had data for t1/2 of Sotatercept Following a Single Dose
t1/2 is the elimination half-life of study drug: the time it takes for half of the study drug in the blood plasma to dissipate.
Outcome measures
| Measure |
Sotatercept 15 mg
n=10 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=3 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Apparent Terminal Half-life (t1/2) of Sotatercept Following a Single Dose
|
18.98 Days
Standard Deviation 7.96
|
30.84 Days
Standard Deviation 9.46
|
SECONDARY outcome
Timeframe: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43Population: All participants who received at least 1 dose of study treatment and had data for CL/F of Sotatercept Following a Single Dose
Apparent serum CL is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Sotatercept 15 mg
n=10 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=3 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Apparent Serum Clearance (CL/F) of Sotatercept Following a Single Dose
|
479.36 mL/day
Standard Deviation 254.44
|
220.14 mL/day
Standard Deviation 31.17
|
SECONDARY outcome
Timeframe: Pre-dose 1 Day 1, 4 hours post-dose Day 1, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 36, pre-dose 2 Day 43Population: All participants who received at least 1 dose of study treatment and had data for Vz/F of Sotatercept Following a Single Dose
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
Sotatercept 15 mg
n=10 Participants
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=3 Participants
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) Following a Single Dose of Sotatercept
|
11944.60 mL
Standard Deviation 7172.84
|
9849.80 mL
Standard Deviation 3449.33
|
Adverse Events
Sotatercept 15 mg
Serious events: 4 serious events
Other events: 14 other events
Deaths: 6 deaths
Sotatercept 30 mg
Serious events: 8 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Sotatercept 15 mg
n=14 participants at risk
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=11 participants at risk
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
36.4%
4/11 • Number of events 5 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Asthenia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Death
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Malnutrition
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Renal and urinary disorders
Renal failure
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Renal and urinary disorders
Renal failure acute
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
Other adverse events
| Measure |
Sotatercept 15 mg
n=14 participants at risk
Participants received sotatercept 15 mg by SC injection once every 42 days, up to four doses.
|
Sotatercept 30 mg
n=11 participants at risk
Participants received sotatercept 30 mg by SC injection once every 42 days, up to four doses.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.1%
1/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
4/14 • Number of events 34 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
54.5%
6/11 • Number of events 17 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
2/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 4 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.4%
3/14 • Number of events 23 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
36.4%
4/11 • Number of events 9 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.4%
3/14 • Number of events 28 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
45.5%
5/11 • Number of events 21 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Cardiac disorders
Atrial tachycardia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Cardiac disorders
Tachycardia
|
14.3%
2/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Eye disorders
Cataract
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Eye disorders
Glaucoma
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Eye disorders
Ocular icterus
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Eye disorders
Photophobia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
6/14 • Number of events 9 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Poor dental condition
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
Vomiting
|
35.7%
5/14 • Number of events 6 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Asthenia
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Catheter site erythema
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Catheter site haemorrhage
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Catheter site inflammation
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Chills
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Device occlusion
|
14.3%
2/14 • Number of events 4 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Face oedema
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Fatigue
|
50.0%
7/14 • Number of events 14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
36.4%
4/11 • Number of events 6 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Oedema peripheral
|
28.6%
4/14 • Number of events 9 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
36.4%
4/11 • Number of events 6 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Fungal skin infection
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Labyrinthitis
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Oral candidiasis
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Urethritis
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 4 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Investigations
Blood iron decreased
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Investigations
Haemoglobin decreased
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Investigations
Lymph node palpable
|
7.1%
1/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Investigations
Protein total decreased
|
7.1%
1/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Investigations
Weight decreased
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
2/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Fluid retention
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
28.6%
4/14 • Number of events 22 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
36.4%
4/11 • Number of events 7 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
2/14 • Number of events 9 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
2/14 • Number of events 24 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Number of events 5 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
36.4%
4/11 • Number of events 4 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
2/14 • Number of events 19 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
27.3%
3/11 • Number of events 8 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • Number of events 4 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 6 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypophagia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 6 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mediastinal neoplasm
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Amnesia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Diabetic neuropathy
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Dizziness postural
|
7.1%
1/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Hypoaesthesia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Lethargy
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Nerve compression
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
Affect lability
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
Feeling of despair
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.4%
3/14 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
36.4%
4/11 • Number of events 4 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
2/14 • Number of events 2 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Social circumstances
Tobacco user
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Vascular disorders
Flushing
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Vascular disorders
Hypertension
|
14.3%
2/14 • Number of events 4 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
18.2%
2/11 • Number of events 3 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/14 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Vascular disorders
Phlebitis superficial
|
7.1%
1/14 • Number of events 1 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
0.00%
0/11 • Up to approximately 6 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication.
- Publication restrictions are in place
Restriction type: OTHER