Trial Outcomes & Findings for An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure (NCT NCT00803101)
NCT ID: NCT00803101
Last Updated: 2015-04-06
Results Overview
Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. 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
176 participants
Primary outcome timeframe
From the start of infusion until the end of surgery
Results posted on
2015-04-06
Participant Flow
Participant milestones
| Measure |
Beriplex® P/N
Beriplex® P/N: Intravenous infusion, dosage depending on baseline international normalized ratio (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
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
88
|
|
Overall Study
COMPLETED
|
70
|
66
|
|
Overall Study
NOT COMPLETED
|
18
|
22
|
Reasons for withdrawal
| Measure |
Beriplex® P/N
Beriplex® P/N: Intravenous infusion, dosage depending on baseline international normalized ratio (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
|
|---|---|---|
|
Overall Study
Death / Serious Adverse Event
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
7
|
|
Overall Study
Surgery finished outside protocol window
|
1
|
1
|
|
Overall Study
Patient died outside SAE report period
|
1
|
0
|
|
Overall Study
Patient did not attend scheduled visit
|
2
|
1
|
|
Overall Study
Patient did not have surgery
|
1
|
1
|
Baseline Characteristics
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
Baseline characteristics by cohort
| Measure |
Beriplex® P/N
n=87 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
|
Fresh Frozen Plasma
n=81 Participants
Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
32 participants
n=5 Participants
|
39 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Age, Customized
>= 65 to < 75 years
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
34 participants
n=5 Participants
|
23 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of infusion until the end of surgeryPopulation: The Intention-to-Treat Efficacy ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. 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=87 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
|
Fresh Frozen Plasma
n=81 Participants
Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Percentage of Participants Achieving Hemostatic Efficacy During Surgery
|
89.7 percentage of participants
Interval 83.3 to 96.1
|
75.3 percentage of participants
Interval 65.9 to 84.7
|
PRIMARY outcome
Timeframe: 30 minutes after the end of infusionPopulation: The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of 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=87 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
|
Fresh Frozen Plasma
n=81 Participants
Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Percentage of Participants Who Had a Rapid Decrease of the INR
|
55.2 percentage of participants
Interval 44.7 to 65.6
|
9.9 percentage of participants
Interval 3.4 to 16.4
|
SECONDARY outcome
Timeframe: From pre-infusion until 24 h after the start of infusionPopulation: The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio 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=85 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
|
Fresh Frozen Plasma
n=79 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 = 85; 79)
|
32.0 percentage of normal
Standard Deviation 19.93
|
34.8 percentage of normal
Standard Deviation 26.19
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor II, 0.5 h after infusion start (n = 71; 73)
|
84.5 percentage of normal
Standard Deviation 20.92
|
42.5 percentage of normal
Standard Deviation 25.71
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor II, 24 h after infusion start (n = 81; 74)
|
81.4 percentage of normal
Standard Deviation 24.83
|
65.6 percentage of normal
Standard Deviation 23.68
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor VII, pre-infusion start (n = 85; 79)
|
36.8 percentage of normal
Standard Deviation 59.27
|
31.1 percentage of normal
Standard Deviation 25.16
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor VII, 0.5h after infusion start (n = 71; 73)
|
60.1 percentage of normal
Standard Deviation 44.91
|
41.6 percentage of normal
Standard Deviation 42.90
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor VII, 24 h after infusion start (n = 81; 74)
|
85.5 percentage of normal
Standard Deviation 59.76
|
83.7 percentage of normal
Standard Deviation 58.90
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor IX, pre-infusion (n = 85; 79)
|
48.1 percentage of normal
Standard Deviation 25.62
|
55.8 percentage of normal
Standard Deviation 30.50
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor IX, 0.5 h after infusion start (n = 71; 73)
|
71.6 percentage of normal
Standard Deviation 25.38
|
56.2 percentage of normal
Standard Deviation 23.12
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor IX, 24 h after infusion start (n = 81; 74)
|
85.2 percentage of normal
Standard Deviation 33.39
|
93.7 percentage of normal
Standard Deviation 34.25
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor X, pre-infusion (n = 85; 79)
|
19.3 percentage of normal
Standard Deviation 19.32
|
20.8 percentage of normal
Standard Deviation 21.38
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor X, 0.5 h after infusion start (n = 71; 73)
|
82.3 percentage of normal
Standard Deviation 23.33
|
29.8 percentage of normal
Standard Deviation 22.51
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Factor X, 24 h after infusion start (n = 81; 74)
|
78.3 percentage of normal
Standard Deviation 25.62
|
60.2 percentage of normal
Standard Deviation 22.44
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein C, pre-infusion (n = 85; 78)
|
48.8 percentage of normal
Standard Deviation 19.07
|
47.6 percentage of normal
Standard Deviation 21.38
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein C, 0.5 h after infusion start (n = 71; 73)
|
97.1 percentage of normal
Standard Deviation 21.97
|
52.5 percentage of normal
Standard Deviation 18.69
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein C, 24 h after infusion start (n = 81; 74)
|
87.3 percentage of normal
Standard Deviation 26.28
|
78.1 percentage of normal
Standard Deviation 24.80
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein S, pre-infusion (n = 85; 79)
|
45.25 percentage of normal
Standard Deviation 18.498
|
46.18 percentage of normal
Standard Deviation 20.986
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein S, 0.5 h after infusion start (n = 72; 73)
|
80.73 percentage of normal
Standard Deviation 31.489
|
55.82 percentage of normal
Standard Deviation 24.689
|
|
Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S
Protein S, 24 h after infusion start (n = 82; 74)
|
75.97 percentage of normal
Standard Deviation 36.449
|
69.32 percentage of normal
Standard Deviation 27.504
|
SECONDARY outcome
Timeframe: From the start of surgery until 24 h after the start of surgeryPopulation: The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
The total units of transfused PRBCs or whole blood
Outcome measures
| Measure |
Beriplex® P/N
n=87 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
|
Fresh Frozen Plasma
n=81 Participants
Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood
|
0.3 units of PRBCs or whole blood
Standard Deviation 0.90
|
0.4 units of PRBCs or whole blood
Standard Deviation 1.02
|
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 infusionPopulation: The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio 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=87 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
|
Fresh Frozen Plasma
n=81 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
|
1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
1 h
|
54 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
3 h
|
77 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
6 h
|
81 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
12 h
|
83 percentage of participants
|
32 percentage of participants
|
|
Percentage of Participants With INR Correction at Various Times After the Start of Infusion
24 h
|
87 percentage of participants
|
48 percentage of participants
|
SECONDARY outcome
Timeframe: From the start of surgery until 24 h after the start of surgeryPopulation: The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Red blood cells were PRBCs and whole blood
Outcome measures
| Measure |
Beriplex® P/N
n=87 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
|
Fresh Frozen Plasma
n=81 Participants
Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Percentage of Participants Who Received Red Blood Cells
|
16.1 percentage of participants
|
14.8 percentage of 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 SAEsPopulation: The Intention-to-Treat Safety (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. TEAEs were defined as adverse events that developed or worsened following exposure to investigational medicinal product. Treatment-related TEAEs were events whose relationship to study treatment was related, probably related, or possibly related in the opinion of the investigator. Treatment emergent adverse events with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent serious adverse events (SAEs).
Outcome measures
| Measure |
Beriplex® P/N
n=88 Participants
Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
|
Fresh Frozen Plasma
n=88 Participants
Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Overall Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
49 participants
|
53 participants
|
|
Overall Treatment-emergent Adverse Events (TEAEs)
At least possibly treatment-related TEAE
|
8 participants
|
15 participants
|
|
Overall Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
|
22 participants
|
23 participants
|
|
Overall Treatment-emergent Adverse Events (TEAEs)
Death
|
4 participants
|
8 participants
|
Adverse Events
Beriplex® P/N
Serious events: 22 serious events
Other events: 41 other events
Deaths: 0 deaths
Fresh Frozen Plasma
Serious events: 23 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Beriplex® P/N
n=88 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=88 participants at risk
Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Pneumonia aspiration
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Acute pulmonary oedema
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Acute respiratory failure
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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 embolism
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Upper gastrointestinal haemorrhage
|
2.3%
2/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Abdominal pain upper
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Intestinal obstruction
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Intra-abdominal haematoma
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Retroperitoneal haemorrhage
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Acute myocardial infarction
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
Atrial fibrillation
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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 arrest
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Cardiopulmonary failure
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Sepsis
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
Bronchopneumonia
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Clostridium difficile colitis
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Urosepsis
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Thrombosis
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Venous insufficiency
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Post procedural discharge
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Post procedural haemorrhage
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Vena cava injury
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Coma
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Dementia
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Embolic cerebral infarction
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Death
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Systemic inflammatory response syndrome
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Wound necrosis
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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)
Tumor haemorrhage
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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 acute
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Soft tissue necrosis
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
|
Surgical and medical procedures
Wound drainage
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Hypertension
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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=88 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=88 participants at risk
Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
11.4%
10/88 • Number of events 10 • 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.
The AEs presented were serious and non-serious (other) 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.
|
4.5%
4/88 • Number of events 4 • 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.
The AEs presented were serious and non-serious (other) 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
|
8.0%
7/88 • Number of events 7 • 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.
The AEs presented were serious and non-serious (other) 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.
|
4.5%
4/88 • Number of events 4 • 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.
The AEs presented were serious and non-serious (other) 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
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Dysphagia
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
8.0%
7/88 • Number of events 7 • 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.
The AEs presented were serious and non-serious (other) 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.
|
9.1%
8/88 • Number of events 9 • 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.
The AEs presented were serious and non-serious (other) 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
Hypocalcaemia
|
4.5%
4/88 • Number of events 4 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Hyperglycaemia
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
Decreased appetite
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Atrial fibrillation
|
5.7%
5/88 • Number of events 6 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
|
5.7%
5/88 • Number of events 5 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
Ventricular tachycardia
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
Ventricular extrasystoles
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
5.7%
5/88 • Number of events 5 • 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.
The AEs presented were serious and non-serious (other) 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
Hypoxia
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Productive cough
|
4.5%
4/88 • Number of events 4 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Atelectasis
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Cough
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Rales
|
0.00%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
|
10.2%
9/88 • Number of events 9 • 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.
The AEs presented were serious and non-serious (other) 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.
|
10.2%
9/88 • Number of events 9 • 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.
The AEs presented were serious and non-serious (other) 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
Thrombocytopenia
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Oedema peripheral
|
6.8%
6/88 • Number of events 6 • 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.
The AEs presented were serious and non-serious (other) 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.
|
6.8%
6/88 • Number of events 6 • 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.
The AEs presented were serious and non-serious (other) 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
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
5.7%
5/88 • Number of events 5 • 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.
The AEs presented were serious and non-serious (other) 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
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Confusional state
|
3.4%
3/88 • Number of events 4 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
Decubitus ulcer
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Erythema
|
2.3%
2/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
Pruritis
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
|
8.0%
7/88 • Number of events 7 • 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.
The AEs presented were serious and non-serious (other) 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.
|
6.8%
6/88 • Number of events 6 • 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.
The AEs presented were serious and non-serious (other) 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
Incision site pain
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Contusion
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Muscle spasms
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Pain in extremity
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
2.3%
2/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Joint swelling
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Tremor
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Urinary retention
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
Haematuria
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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.
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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
Body temperature increased
|
3.4%
3/88 • Number of events 3 • 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.
The AEs presented were serious and non-serious (other) 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.
|
1.1%
1/88 • Number of events 1 • 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.
The AEs presented were serious and non-serious (other) 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
Blood glucose increased
|
2.3%
2/88 • Number of events 2 • 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.
The AEs presented were serious and non-serious (other) 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%
0/88 • 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.
The AEs presented were serious and non-serious (other) 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