Trial Outcomes & Findings for Cook IVC Filter Study (NCT NCT02046096)
NCT ID: NCT02046096
Last Updated: 2022-01-20
Results Overview
The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
473 participants
Primary outcome timeframe
12 months
Results posted on
2022-01-20
Participant Flow
Participant milestones
| Measure |
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
324
|
|
Overall Study
COMPLETED
|
105
|
223
|
|
Overall Study
NOT COMPLETED
|
44
|
101
|
Reasons for withdrawal
| Measure |
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
|---|---|---|
|
Overall Study
Death
|
28
|
45
|
|
Overall Study
Lost to Follow-up
|
9
|
20
|
|
Overall Study
Withdrawal by Subject
|
5
|
17
|
|
Overall Study
Other endpoint
|
2
|
19
|
Baseline Characteristics
Cook IVC Filter Study
Baseline characteristics by cohort
| Measure |
Günther Tulip® Vena Cava Filter
n=149 Participants
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Cook Celect® Vena Cava Filters
n=324 Participants
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 15.4 • n=93 Participants
|
60.7 years
STANDARD_DEVIATION 16.4 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 16.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=93 Participants
|
140 Participants
n=4 Participants
|
202 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=93 Participants
|
184 Participants
n=4 Participants
|
271 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian/White
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
17 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black/Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
12 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino/White
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
120 Participants
n=93 Participants
|
244 Participants
n=4 Participants
|
364 Participants
n=27 Participants
|
|
Body Mass Index( BMI)
|
31.3 kg/m^2
STANDARD_DEVIATION 8.2 • n=93 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 7.6 • n=4 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 7.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The hypothesis was tested only for patients receiving Celect filters, in accordance with the study protocol.
The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).
Outcome measures
| Measure |
Cook Celect® Vena Cava Filters
n=324 Participants
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Total
Combined Patient Population
|
|---|---|---|---|
|
The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.
|
317 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The CIP defined methodology for analysis of the primary endpoint relied on Kaplan-Meier estimation. However, a large number of patients were censored (n=235), primarily due to filter retrieval (n=204). The hypothesis was tested only for patients receiving Celect filters, in accordance with the study protocol.
MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death. Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT. Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention. Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.
Outcome measures
| Measure |
Cook Celect® Vena Cava Filters
n=324 Participants
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Total
Combined Patient Population
|
|---|---|---|---|
|
The Rate of 12-month Freedom From Major Adverse Events (MAEs)
|
81.5 Rate of Freedom from MAE (%)
Standard Error 4.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The hypothesis was only tested for patients receiving Celect filters, in accordance with the protocol.
MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death. A filter retrieval is considered a successful safety result through 12 months, regardless of when the retrieval occurred.
Outcome measures
| Measure |
Cook Celect® Vena Cava Filters
n=324 Participants
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Total
Combined Patient Population
|
|---|---|---|---|
|
Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).
|
281 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsRate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling for the combined patient population (i.e., the Celect and Günther Tulip strata). The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).
Outcome measures
| Measure |
Cook Celect® Vena Cava Filters
n=324 Participants
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Günther Tulip® Vena Cava Filter
n=149 Participants
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Total
n=473 Participants
Combined Patient Population
|
|---|---|---|---|
|
Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling
|
317 Participants
|
147 Participants
|
464 Participants
|
SECONDARY outcome
Timeframe: 12 monthsMAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death. Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT. Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention. Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.
Outcome measures
| Measure |
Cook Celect® Vena Cava Filters
n=324 Participants
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Günther Tulip® Vena Cava Filter
n=149 Participants
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Total
n=473 Participants
Combined Patient Population
|
|---|---|---|---|
|
Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)
|
281 Participants
|
135 Participants
|
416 Participants
|
SECONDARY outcome
Timeframe: 12 monthsFilter interaction with IVC is defined as : Grade 2: Filter strut is entirely outside of the IVC lumen and within the retroperitoneum as evidenced by a "halo" of retroperitoneal fat around axially viewed strut. Grade 3: Filter strut is touching, impressing, or perforating another organ (e.g., liver, bowel, aorta, psoas muscle, vertebral body, lymph nodes). Filter migration : Change in filter position compared to its deployed position (cranial or caudal). Filter fracture : Any loss of structural integrity (breakage or separation) of the filter identified by imaging or autopsy. Documented by imaging or at autopsy. Filter embolization : Post-placement movement of the filter or its components to a distant anatomic site completely out of the target zone (i.e., heart/lungs). Documented by imaging or autopsy.
Outcome measures
| Measure |
Cook Celect® Vena Cava Filters
n=324 Participants
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Günther Tulip® Vena Cava Filter
n=149 Participants
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Total
n=473 Participants
Combined Patient Population
|
|---|---|---|---|
|
Number of Participants With Freedom From Grade 2 or Grade 3 Filter Leg Interaction With IVC, Filter Migration, Filter Fracture, and Filter Embolization at 12-month.
|
274 Participants
|
131 Participants
|
405 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Patients with filter retrieval attempted
The filters may be retrieved if clinically indicated. The IVC filter and IVC were assessed on imaging before a retrieval attempt. (The filter retrieval rate= the total number of filter retrieved / the total number of filter retrieval attempted)
Outcome measures
| Measure |
Cook Celect® Vena Cava Filters
n=230 Participants
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filters: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Günther Tulip® Vena Cava Filter
n=105 Participants
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Total
n=335 Participants
Combined Patient Population
|
|---|---|---|---|
|
Filter Retrieval Rate
|
219 Participants
|
99 Participants
|
318 Participants
|
Adverse Events
Cook Celect® Vena Cava Filters
Serious events: 76 serious events
Other events: 0 other events
Deaths: 45 deaths
Günther Tulip® Vena Cava Filter
Serious events: 43 serious events
Other events: 0 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Cook Celect® Vena Cava Filters
n=324 participants at risk
Cook Celect® Vena Cava Filters
Cook Celect® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
Günther Tulip® Vena Cava Filter
n=149 participants at risk
Günther Tulip® Vena Cava Filter
Günther Tulip® Vena Cava Filter: Temporary or permanent filter placement for the prevention of pulmonary embolism
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
2/324 • Number of events 2 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Cardiac disorders
Acute left ventricular failure
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Cardiac disorders
Angina unstable
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
4/324 • Number of events 4 • 2 years
|
1.3%
2/149 • Number of events 3 • 2 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Cardiac disorders
Atrial tachycardia
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiac failure acute
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.62%
2/324 • Number of events 2 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiogenic shock
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Eye disorders
Cataract
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
4/324 • Number of events 4 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Gastrointestinal disorders
Faecaloma
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastritis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
4/324 • Number of events 4 • 2 years
|
2.7%
4/149 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
General disorders
Chest pain
|
0.93%
3/324 • Number of events 3 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
General disorders
Malaise
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
General disorders
Peripheral swelling
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
General disorders
Pyrexia
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
General disorders
Systemic inflammatory response syndrome
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
General disorders
Vascular stent stenosis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Infections and infestations
Abscess rupture
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Infections and infestations
Cellulitis
|
0.93%
3/324 • Number of events 3 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Clostridium colitis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Clostridium difficile infection
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Colon gangrene
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Infections and infestations
Herpes simplex encephalitis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Infection
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Infections and infestations
Osteomyelitis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Peritonitis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Peritonitis bacterial
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Pneumonia
|
1.9%
6/324 • Number of events 6 • 2 years
|
1.3%
2/149 • Number of events 2 • 2 years
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Infections and infestations
Pyelonephritis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Infections and infestations
Sepsis
|
0.62%
2/324 • Number of events 2 • 2 years
|
1.3%
2/149 • Number of events 2 • 2 years
|
|
Infections and infestations
Septic shock
|
0.93%
3/324 • Number of events 3 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Sinusitis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Streptococcal sepsis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.62%
2/324 • Number of events 2 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 2 • 2 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Aortic pseudoaneurysm
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Injury, poisoning and procedural complications
Loss of anatomical alignment after fracture reduction
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.93%
3/324 • Number of events 3 • 2 years
|
0.00%
0/149 • 2 years
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Investigations
Ammonia increased
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Investigations
CSF volume increased
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Investigations
International normalized ratio increased
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/324 • 2 years
|
2.0%
3/149 • Number of events 3 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.31%
1/324 • Number of events 3 • 2 years
|
0.00%
0/149 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/324 • 2 years
|
1.3%
2/149 • Number of events 2 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Nervous system disorders
Alcoholic seizure
|
0.31%
1/324 • Number of events 2 • 2 years
|
0.00%
0/149 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.62%
2/324 • Number of events 2 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Nervous system disorders
Intracranial mass
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Nervous system disorders
Ischaemic stroke
|
0.93%
3/324 • Number of events 3 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Nervous system disorders
Jugular vein occlusion
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Nervous system disorders
Myelopathy
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Product Issues
Device breakage
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Product Issues
Device capturing issue
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Product Issues
Device occlusion
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Psychiatric disorders
Confusional state
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.31%
1/324 • Number of events 1 • 2 years
|
1.3%
2/149 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Haematuria
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.31%
1/324 • Number of events 1 • 2 years
|
1.3%
2/149 • Number of events 4 • 2 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Renal and urinary disorders
Renal failure
|
0.93%
3/324 • Number of events 3 • 2 years
|
1.3%
2/149 • Number of events 2 • 2 years
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.62%
2/324 • Number of events 2 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
2/324 • Number of events 2 • 2 years
|
0.00%
0/149 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
8/324 • Number of events 9 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.31%
1/324 • Number of events 2 • 2 years
|
0.00%
0/149 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.93%
3/324 • Number of events 3 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.31%
1/324 • Number of events 1 • 2 years
|
2.7%
4/149 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Intra-thoracic aortic aneurysm repair
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Spinal operation
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Stem cell transplant
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Vascular disorders
Aortic occlusion
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Vascular disorders
Arteriovenous fistula
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Vascular disorders
Brachiocephalic vein occlusion
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Vascular disorders
Deep vein thrombosis
|
5.9%
19/324 • Number of events 24 • 2 years
|
4.0%
6/149 • Number of events 7 • 2 years
|
|
Vascular disorders
Haematoma
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Vascular disorders
Iliac vein stenosis
|
0.62%
2/324 • Number of events 2 • 2 years
|
0.00%
0/149 • 2 years
|
|
Vascular disorders
Ischaemic limb pain
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 2 • 2 years
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/324 • 2 years
|
0.67%
1/149 • Number of events 1 • 2 years
|
|
Vascular disorders
Vena cava thrombosis
|
1.5%
5/324 • Number of events 6 • 2 years
|
2.0%
3/149 • Number of events 3 • 2 years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.31%
1/324 • Number of events 1 • 2 years
|
0.00%
0/149 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Alan Saunders, MS, RAC; Manager, Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60