Trial Outcomes & Findings for Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. (NCT NCT02740335)
NCT ID: NCT02740335
Last Updated: 2023-03-08
Results Overview
Hemostatic Efficacy rated by the Independent Endpoint Adjudication Committee based on a 1 to 4 point hemostatic efficacy scale, taking into account blood loss and transfusion requirements in the context of the surgery. Hemostatic efficacy was assessed based on objective criteria in the categories 'excellent', 'good', 'moderate', or 'none'. Ratings of 'excellent' and 'good' were considered as 'effective' hemostasis, while ratings of 'moderate' and 'none' were considered as 'ineffective' hemostasis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
208 participants
Primary outcome timeframe
At the end of the surgery
Results posted on
2023-03-08
Participant Flow
Participant milestones
| Measure |
Octaplex
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
103
|
|
Overall Study
COMPLETED
|
105
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
Baseline characteristics by cohort
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive 1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 Years
n=5 Participants
|
66.8 Years
n=7 Participants
|
66.2 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Pre-Infusion Anticoagulation Therapy
Sol. Fraxiparine (nadroparin calcium)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Pre-Infusion Anticoagulation Therapy
Vitamin K Antagonist
|
105 participants
n=5 Participants
|
103 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
History of TEE
Presence of Embolic or Thrombotic Event
|
13 participants
n=5 Participants
|
18 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
History of TEE
Absence of Embolic or Thrombotic Event
|
92 participants
n=5 Participants
|
85 participants
n=7 Participants
|
177 participants
n=5 Participants
|
|
Type of Surgey
Cardiothoracic Surgery
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Type of Surgey
Orthopaedic Surgery
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Type of Surgey
Other Surgery Type
|
93 participants
n=5 Participants
|
94 participants
n=7 Participants
|
187 participants
n=5 Participants
|
|
Estimated Average Blood Loss
≥200 mL
|
55 participants
n=5 Participants
|
50 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Estimated Average Blood Loss
≥100 mL but <200 mL
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Estimated Average Blood Loss
≥50mL but <100 mL
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of the surgeryHemostatic Efficacy rated by the Independent Endpoint Adjudication Committee based on a 1 to 4 point hemostatic efficacy scale, taking into account blood loss and transfusion requirements in the context of the surgery. Hemostatic efficacy was assessed based on objective criteria in the categories 'excellent', 'good', 'moderate', or 'none'. Ratings of 'excellent' and 'good' were considered as 'effective' hemostasis, while ratings of 'moderate' and 'none' were considered as 'ineffective' hemostasis.
Outcome measures
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Hemostatic Efficacy Rating by IEAB
Excellent - 4
|
41 Participants
|
50 Participants
|
|
Hemostatic Efficacy Rating by IEAB
Good - 3
|
58 Participants
|
47 Participants
|
|
Hemostatic Efficacy Rating by IEAB
Moderate - 2
|
6 Participants
|
6 Participants
|
|
Hemostatic Efficacy Rating by IEAB
None - 1
|
0 Participants
|
0 Participants
|
|
Hemostatic Efficacy Rating by IEAB
Effective
|
99 Participants
|
97 Participants
|
|
Hemostatic Efficacy Rating by IEAB
Ineffective
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: At the end of surgeryTo demostrate clinical non-inferiority of treatment with Octaplex to treatment with Beriplex P/N (Kcentra) with respect to hemostatic success. Effective hemostatis includes Excellent and Good ratings, while Ineffective hemostasis includes Moderate, None and missing ratings from Global hemostatic efficacy observed by IEAB
Outcome measures
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Dichotomous Hemostasis Success
Effective
|
99 Participants
|
97 Participants
|
|
Dichotomous Hemostasis Success
Ineffective
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 minutes after the end of infusionNumber of patients with an international normalized ratio (INR) value of less or equal to 1.5 at 30 min (± 15 min) after the end of infusion.
Outcome measures
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Measuring of International Normalized Ratio (INR) to ≤ 1.5
<=1.5
|
82 Participants
|
74 Participants
|
|
Measuring of International Normalized Ratio (INR) to ≤ 1.5
> 1.5
|
23 Participants
|
29 Participants
|
|
Measuring of International Normalized Ratio (INR) to ≤ 1.5
Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 minutes after the end of infusionChange in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor II The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences.
Outcome measures
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Coagulation Factor II Levels
|
49.5 mg/dL
Interval 37.0 to 76.5
|
51.0 mg/dL
Interval 37.5 to 69.0
|
SECONDARY outcome
Timeframe: 30 minutes after the end of infusionChange in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor VII The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences.
Outcome measures
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Coagulation Factor VII Levels
|
35.0 mg/dL
Interval 21.0 to 55.0
|
23.0 mg/dL
Interval 15.0 to 43.0
|
SECONDARY outcome
Timeframe: 30 minutes after the end of infusionChange in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor II Factor IX The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences.
Outcome measures
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Coagulation Factor IX Levels
|
33.0 m/dL
Interval 17.0 to 56.0
|
31.5 m/dL
Interval 19.0 to 51.0
|
SECONDARY outcome
Timeframe: 30 minutes after the end of infusionChange in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor X The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences.
Outcome measures
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Coagulation Factor X Levels
|
50.0 mg/dL
Interval 35.0 to 73.0
|
63.0 mg/dL
Interval 49.0 to 88.0
|
SECONDARY outcome
Timeframe: At the end of surgeryNumber of patients receiving red blood cells (RBC) during the surgery
Outcome measures
| Measure |
Octaplex
n=105 Participants
Participants to receive1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 Participants
Participants to receive1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Number of Patients Requiring Red Blood Cells (RBC)
Received RBC
|
4 Participants
|
3 Participants
|
|
Number of Patients Requiring Red Blood Cells (RBC)
Did Not Receive RBC
|
101 Participants
|
100 Participants
|
Adverse Events
Octaplex
Serious events: 13 serious events
Other events: 86 other events
Deaths: 5 deaths
Beriplex P/N (Kcentra)
Serious events: 6 serious events
Other events: 80 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Octaplex
n=105 participants at risk
Participants to receive 1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 participants at risk
Participants to receive 1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Infections and infestations
Pneumonia
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Gastrointestinal disorders
Mesenteric Haematoma
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Gastrointestinal disorders
Proctitis
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
General disorders
Death
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Infections and infestations
Orchitis
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Anastomotic Haemmorhage
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Failure to Anastomose
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Haemorrhage
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Stage IV
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Nervous system disorders
Cerebral Infarction
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Vascular disorders
Shock
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Vascular disorders
Shock Haemorrhagic
|
0.00%
0/105 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
Other adverse events
| Measure |
Octaplex
n=105 participants at risk
Participants to receive 1 Octaplex infusion intravenously
Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
Beriplex P/N (Kcentra)
n=103 participants at risk
Participants to receive 1 Kcentra infusion intravenously
Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
6/105 • Number of events 6 • 45 days after surgery
|
5.8%
6/103 • Number of events 6 • 45 days after surgery
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
3/105 • Number of events 3 • 45 days after surgery
|
4.9%
5/103 • Number of events 5 • 45 days after surgery
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.9%
2/105 • Number of events 2 • 45 days after surgery
|
2.9%
3/103 • Number of events 3 • 45 days after surgery
|
|
Gastrointestinal disorders
Dyschezia
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
2.9%
3/103 • Number of events 3 • 45 days after surgery
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/105 • 45 days after surgery
|
2.9%
3/103 • Number of events 3 • 45 days after surgery
|
|
Cardiac disorders
Cardiac AEs
|
4.8%
5/105 • Number of events 5 • 45 days after surgery
|
6.8%
7/103 • Number of events 7 • 45 days after surgery
|
|
General disorders
Asthenia
|
12.4%
13/105 • Number of events 13 • 45 days after surgery
|
17.5%
18/103 • Number of events 18 • 45 days after surgery
|
|
General disorders
Catheter Site Related Reaction
|
3.8%
4/105 • Number of events 4 • 45 days after surgery
|
1.9%
2/103 • Number of events 2 • 45 days after surgery
|
|
General disorders
Hyperthermia
|
2.9%
3/105 • Number of events 3 • 45 days after surgery
|
1.9%
2/103 • Number of events 2 • 45 days after surgery
|
|
General disorders
Pyrexia
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
2.9%
3/103 • Number of events 3 • 45 days after surgery
|
|
Infections and infestations
Pneumonia
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
2.9%
3/103 • Number of events 3 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
47.6%
50/105 • Number of events 50 • 45 days after surgery
|
48.5%
50/103 • Number of events 50 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complications
|
14.3%
15/105 • Number of events 15 • 45 days after surgery
|
14.6%
15/103 • Number of events 15 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Procedural Vomiting
|
3.8%
4/105 • Number of events 4 • 45 days after surgery
|
0.00%
0/103 • 45 days after surgery
|
|
Injury, poisoning and procedural complications
Suture Related Complication
|
1.9%
2/105 • Number of events 2 • 45 days after surgery
|
3.9%
4/103 • Number of events 4 • 45 days after surgery
|
|
Investigations
Blood Pressure Increase
|
0.00%
0/105 • 45 days after surgery
|
4.9%
5/103 • Number of events 5 • 45 days after surgery
|
|
Investigations
Body Temperature Increase
|
0.00%
0/105 • 45 days after surgery
|
3.9%
4/103 • Number of events 4 • 45 days after surgery
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
4.8%
5/105 • Number of events 5 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
3.8%
4/105 • Number of events 4 • 45 days after surgery
|
6.8%
7/103 • Number of events 7 • 45 days after surgery
|
|
Nervous system disorders
Nervous System Disorders
|
5.7%
6/105 • Number of events 6 • 45 days after surgery
|
0.97%
1/103 • Number of events 1 • 45 days after surgery
|
|
Renal and urinary disorders
Dysuria
|
4.8%
5/105 • Number of events 5 • 45 days after surgery
|
1.9%
2/103 • Number of events 2 • 45 days after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
1.9%
2/105 • Number of events 2 • 45 days after surgery
|
4.9%
5/103 • Number of events 5 • 45 days after surgery
|
|
Vascular disorders
Vascular Disorders
|
0.95%
1/105 • Number of events 1 • 45 days after surgery
|
5.8%
6/103 • Number of events 6 • 45 days after surgery
|
|
Vascular disorders
Hypotension
|
0.00%
0/105 • 45 days after surgery
|
2.9%
3/103 • Number of events 3 • 45 days after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place