Trial Outcomes & Findings for Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy (NCT NCT00708435)
NCT ID: NCT00708435
Last Updated: 2014-02-03
Results Overview
Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
216 participants
Primary outcome timeframe
At 1 and 4 hours after the end of infusion
Results posted on
2014-02-03
Participant Flow
Participant milestones
| Measure |
Beriplex® P/N
Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.
|
Fresh Frozen Plasma
Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
109
|
|
Overall Study
COMPLETED
|
82
|
92
|
|
Overall Study
NOT COMPLETED
|
25
|
17
|
Reasons for withdrawal
| Measure |
Beriplex® P/N
Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.
|
Fresh Frozen Plasma
Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.
|
|---|---|---|
|
Overall Study
Death / Serious Adverse Event
|
10
|
5
|
|
Overall Study
Lost to Follow-up
|
9
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Intervention by primary care physician
|
1
|
0
|
|
Overall Study
Refused hospitalization
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
Baseline characteristics by cohort
| Measure |
Beriplex® P/N
n=107 Participants
Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=109 Participants
Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 to < 75 years
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Customized
≥ 75 years
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 1 and 4 hours after the end of infusionPopulation: The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none".
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed
|
72.4 percentage of participants
Interval 63.6 to 81.3
|
65.4 percentage of participants
Interval 56.2 to 74.5
|
PRIMARY outcome
Timeframe: 30 minutes after end of infusionPopulation: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)
|
62.2 percentage of participants
Interval 52.6 to 71.8
|
9.6 percentage of participants
Interval 3.9 to 15.3
|
SECONDARY outcome
Timeframe: At 3 and 6 hours after the start of infusionPopulation: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none".
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding
|
73.5 percentage of participants
Interval 64.7 to 82.2
|
67.3 percentage of participants
Interval 58.3 to 76.3
|
SECONDARY outcome
Timeframe: Before infusion and up to 3 h after the start of infusionPopulation: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
The incremental IVR \[(IU/dL)/(IU/kg)\] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = \[maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)\]/{\[exact dose of component in drug administered (IU)\]/\[body weight (kg)\]}.
Outcome measures
| Measure |
Beriplex® P/N
n=97 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex
Factor II
|
2.00 (IU/dL)/(IU/kg body weight)
Standard Deviation 0.879
|
—
|
|
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex
Factor VII
|
2.15 (IU/dL)/(IU/kg body weight)
Standard Deviation 2.958
|
—
|
|
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex
Factor IX
|
1.29 (IU/dL)/(IU/kg body weight)
Standard Deviation 0.711
|
—
|
|
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex
Factor X
|
1.96 (IU/dL)/(IU/kg body weight)
Standard Deviation 0.871
|
—
|
|
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex
Protein C
|
2.04 (IU/dL)/(IU/kg body weight)
Standard Deviation 0.958
|
—
|
|
Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex
Protein S
|
2.17 (IU/dL)/(IU/kg body weight)
Standard Deviation 1.661
|
—
|
SECONDARY outcome
Timeframe: From preinfusion until 24 h after the start of infusionPopulation: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor II, pre-infusion (n = 98; 103)
|
20.1 percentage of normal
Standard Deviation 14.56
|
22.3 percentage of normal
Standard Deviation 22.39
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor II, 0.5 h after infusion start (n = 88; 90)
|
87.5 percentage of normal
Standard Deviation 44.48
|
31.9 percentage of normal
Standard Deviation 22.55
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor II, 24 h after infusion start (n = 92; 99)
|
77.1 percentage of normal
Standard Deviation 22.06
|
58.1 percentage of normal
Standard Deviation 19.55
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor VII, pre-infusion (n = 98; 103)
|
25.9 percentage of normal
Standard Deviation 35.01
|
23.5 percentage of normal
Standard Deviation 23.45
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor VII, 0.5h after infusion start (n = 88; 90)
|
60.5 percentage of normal
Standard Deviation 45.23
|
34.6 percentage of normal
Standard Deviation 26.18
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor VII, 24 h after infusion start (n = 92; 99)
|
114.8 percentage of normal
Standard Deviation 165.28
|
101.3 percentage of normal
Standard Deviation 79.01
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor IX, pre-infusion (n = 98; 103)
|
36.1 percentage of normal
Standard Deviation 22.56
|
39.0 percentage of normal
Standard Deviation 27.56
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor IX, 0.5 h after infusion start (n = 88; 90)
|
76.8 percentage of normal
Standard Deviation 35.47
|
47.7 percentage of normal
Standard Deviation 26.78
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor IX, 24 h after infusion start (n = 92; 99)
|
88.5 percentage of normal
Standard Deviation 35.65
|
93.0 percentage of normal
Standard Deviation 29.95
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor X, pre-infusion (n = 98; 102)
|
13.0 percentage of normal
Standard Deviation 11.25
|
14.7 percentage of normal
Standard Deviation 18.83
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor X, 0.5 h after infusion start (n = 88; 90)
|
99.8 percentage of normal
Standard Deviation 56.07
|
23.9 percentage of normal
Standard Deviation 20.40
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor X, 24 h after infusion start (n = 92; 99)
|
83.7 percentage of normal
Standard Deviation 27.05
|
58.2 percentage of normal
Standard Deviation 21.78
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein C, pre-infusion (n = 98; 103)
|
39.3 percentage of normal
Standard Deviation 17.15
|
41.1 percentage of normal
Standard Deviation 18.84
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein C, 0.5 h after infusion start (n = 88; 90)
|
110.3 percentage of normal
Standard Deviation 47.37
|
50.9 percentage of normal
Standard Deviation 24.78
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein C, 24h after infusion start (n = 92; 98)
|
90.3 percentage of normal
Standard Deviation 27.19
|
82.8 percentage of normal
Standard Deviation 24.34
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein S, pre-infusion (n = 97; 102)
|
27.8 percentage of normal
Standard Deviation 11.34
|
29.6 percentage of normal
Standard Deviation 12.97
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein S, 0.5 h after infusion start (n = 88; 89)
|
59.4 percentage of normal
Standard Deviation 28.56
|
38.6 percentage of normal
Standard Deviation 20.45
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein S, 24 h after infusion start (n = 91; 97)
|
47.8 percentage of normal
Standard Deviation 16.54
|
45.4 percentage of normal
Standard Deviation 16.00
|
SECONDARY outcome
Timeframe: From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.Population: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
0.5 h
|
4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
1 h
|
69 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
3 h
|
71 percentage of participants
|
9 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
6 h
|
78 percentage of participants
|
16 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
12 h
|
80 percentage of participants
|
36 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
24 h
|
88 percentage of participants
|
58 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.Population: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Percentage of Participants With INR Correction at Various Times After Randomization
2.5 h
|
59 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After Randomization
3 h
|
67 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After Randomization
5 h
|
76 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After Randomization
8 h
|
79 percentage of participants
|
22 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After Randomization
14 h
|
84 percentage of participants
|
38 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After Randomization
26 h
|
90 percentage of participants
|
70 percentage of participants
|
SECONDARY outcome
Timeframe: From the start of infusion until 24 h after the start of infusionPopulation: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Red blood cells were packed red blood cells (PRBCs).
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Transfusion of Red Blood Cells
|
1.4 Units of PRBCs
Standard Deviation 1.77
|
1.2 Units of PRBCs
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: From the start of infusion until 24 h after the start of infusionPopulation: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs.
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Use of Other Blood Products and Hemostatic Agents
|
0.3 Units of blood products
Standard Deviation 1.36
|
0.3 Units of blood products
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Until Day 45Population: The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Outcome measures
| Measure |
Beriplex® P/N
n=98 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=104 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
45-Day All-cause Mortality
|
9 participants
|
5 participants
|
SECONDARY outcome
Timeframe: From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.Population: The ITT-S population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.
Number of participants with TEAEs. Treatment-related AEs were defined as events whose relationship to study treatment was definitely related, probably related, or possibly related in the opinion of the investigator. AEs with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent SAEs. Deaths reported up to and including Day 45; one additional Beriplex death occurred after Day 45.
Outcome measures
| Measure |
Beriplex® P/N
n=103 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=109 Participants
Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Overall Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
66 participants
|
71 participants
|
|
Overall Treatment-emergent Adverse Events (TEAEs)
At least possibly treatment-related TEAE
|
10 participants
|
23 participants
|
|
Overall Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
|
32 participants
|
26 participants
|
|
Overall Treatment-emergent Adverse Events (TEAEs)
Death
|
10 participants
|
5 participants
|
Adverse Events
Beriplex® P/N
Serious events: 32 serious events
Other events: 46 other events
Deaths: 0 deaths
Fresh Frozen Plasma
Serious events: 26 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Beriplex® P/N
n=103 participants at risk
Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=109 participants at risk
Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Cardiac failure
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
1.8%
2/109 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Sinus bradycardia
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Ischaemic stroke
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
1.8%
2/109 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
1.8%
2/109 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Convulsion
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Headache
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Infection
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Septic shock
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Urinary tract infection
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage iv
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Vascular disorders
Deep vein thrombosis
|
0.97%
1/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Vascular disorders
Haematoma
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Vascular disorders
Shock haemorrhagic
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
1.8%
2/109 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Hepatobiliary disorders
Liver disorder
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Renal and urinary disorders
Renal failure acute
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
General disorders
Sudden death
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
3.7%
4/109 • Number of events 5 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Myocardial infarction
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
Other adverse events
| Measure |
Beriplex® P/N
n=103 participants at risk
Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
|
Fresh Frozen Plasma
n=109 participants at risk
Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
General disorders
Oedema peripheral
|
5.8%
6/103 • Number of events 6 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
6.4%
7/109 • Number of events 7 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
General disorders
Pyrexia
|
3.9%
4/103 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
3.7%
4/109 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
General disorders
Chest pain
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Headache
|
9.7%
10/103 • Number of events 10 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
3.7%
4/109 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Nervous system disorders
Dizziness
|
3.9%
4/103 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.9%
2/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
3.7%
4/109 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.9%
4/103 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Constipation
|
4.9%
5/103 • Number of events 5 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
7.3%
8/109 • Number of events 8 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
3.7%
4/109 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
1.8%
2/109 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Tachycardia
|
3.9%
4/103 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Cardiac disorders
Bradycardia
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Investigations
International normalised ratio increased
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
5.5%
6/109 • Number of events 6 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/103 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.97%
1/103 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Psychiatric disorders
Insomnia
|
5.8%
6/103 • Number of events 6 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Psychiatric disorders
Anxiety
|
3.9%
4/103 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
1.8%
2/109 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Psychiatric disorders
Agitation
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Psychiatric disorders
Mental status change
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
4/103 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.92%
1/109 • Number of events 1 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Vascular disorders
Hypotension
|
4.9%
5/103 • Number of events 5 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
2/103 • Number of events 2 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
2.8%
3/109 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.9%
3/103 • Number of events 3 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.9%
4/103 • Number of events 4 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
0.00%
0/109 • From the start of infusion up to the allowed time window of the Day 45 visit for SAEs, and from the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs.
The AEs presented were treatment-emergent AEs (TEAEs). The ITT-S population included all subjects who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. "General disorders" were collected under the MedDRA SOC General disorders and administration site conditions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER