Trial Outcomes & Findings for Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention (NCT NCT01522417)
NCT ID: NCT01522417
Last Updated: 2021-05-13
Results Overview
The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
535 participants
Primary outcome timeframe
48 hours or hospital discharge, whichever came first
Results posted on
2021-05-13
Participant Flow
Date first patient enrolled: 12 June 2012 ; Last patient completed 8 August 2018 The study enrolled both stable and UA/NSTEMI patients scheduled to undergo PCI in one or more native coronary target lesions.
Decision to proceed to PCI, access site for PCI (transradial or transfemoral) and intended oral P2Y12 antagonist agent used post-randomization were all pre-specified prior to randomization to treatment groups.
Participant milestones
| Measure |
Short Tirofiban (Aggrastat)
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
|---|---|---|---|
|
Overall Study
STARTED
|
209
|
202
|
124
|
|
Overall Study
COMPLETED
|
209
|
202
|
124
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
Baseline characteristics by cohort
| Measure |
Short Tirofiban (Aggrastat)
n=209 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
n=202 Participants
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
n=124 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
Total
n=535 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
377 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
202 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
518 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
175 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
451 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
209 participants
n=5 Participants
|
202 participants
n=7 Participants
|
124 participants
n=5 Participants
|
535 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 hours or hospital discharge, whichever came firstPopulation: As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the primary composite endpoint.
The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.
Outcome measures
| Measure |
Short Tirofiban (Aggrastat)
n=202 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
n=194 Participants
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
n=123 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
|---|---|---|---|
|
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
|
69 Participants
|
60 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 48 hours or hospital discharge, whichever came firstPopulation: As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the primary composite endpoint.
The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), or urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia)
Outcome measures
| Measure |
Short Tirofiban (Aggrastat)
n=202 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
n=194 Participants
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
n=123 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
|---|---|---|---|
|
The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization
|
69 Participants
|
60 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 48 hours or hospital discharge, whichever came firstPopulation: mITT
Individual components of death (any-cause), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 major bleeding criteria.
Outcome measures
| Measure |
Short Tirofiban (Aggrastat)
n=209 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
n=202 Participants
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
n=124 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
|---|---|---|---|
|
Individual Components of Death, Urgent Target Revascularization or Major Bleeding
Death
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Individual Components of Death, Urgent Target Revascularization or Major Bleeding
uTVR
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Individual Components of Death, Urgent Target Revascularization or Major Bleeding
REPLACE-2 Major Bleeding
|
0 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 48 hours or hospital discharge, whichever came firstPopulation: As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the individual PPM endpoints.
Individual components of periprocedural myonecrosis (PPM) (defined as ≥ 3 times, ≥ 10 times, ≥ 20 times or ≥ 50 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value)
Outcome measures
| Measure |
Short Tirofiban (Aggrastat)
n=202 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
n=194 Participants
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
n=123 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
|---|---|---|---|
|
Individual Components of Periprocedural Myonecrosis
≥ 3 times ULN
|
69 Participants
|
60 Participants
|
45 Participants
|
|
Individual Components of Periprocedural Myonecrosis
≥ 10 times ULN
|
36 Participants
|
35 Participants
|
28 Participants
|
|
Individual Components of Periprocedural Myonecrosis
≥ 20 times ULN
|
19 Participants
|
27 Participants
|
21 Participants
|
|
Individual Components of Periprocedural Myonecrosis
≥ 50 times ULN
|
11 Participants
|
19 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 48 hours or hospital discharge, whichever came firstThe composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 10 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.
Outcome measures
| Measure |
Short Tirofiban (Aggrastat)
n=202 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
n=194 Participants
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
n=123 Participants
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
|---|---|---|---|
|
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
|
36 Participants
|
35 Participants
|
32 Participants
|
Adverse Events
Short Tirofiban (Aggrastat)
Serious events: 8 serious events
Other events: 45 other events
Deaths: 0 deaths
Eptifibatide (Integrilin)
Serious events: 11 serious events
Other events: 55 other events
Deaths: 1 deaths
Long Tirofiban (Aggrastat)
Serious events: 7 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Short Tirofiban (Aggrastat)
n=209 participants at risk
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
n=202 participants at risk
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
n=124 participants at risk
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
|---|---|---|---|
|
Product Issues
Thrombosis in Device
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Angina Pectoris
|
0.96%
2/209 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.96%
2/209 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Myocardial Infarction
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Post-Procedural Myocardial Infarction
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
1.5%
3/202 • Number of events 3 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Hypotension
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
1.6%
2/124 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Vessel Perforation
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Gastrointestinal Angiodysplasia
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Reproductive system and breast disorders
Testicular Haemorrhage
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Immune system disorders
Contrast Media Allergy
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
Other adverse events
| Measure |
Short Tirofiban (Aggrastat)
n=209 participants at risk
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Short Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
|
Eptifibatide (Integrilin)
n=202 participants at risk
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Eptifibatide: 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Long Tirofiban (Aggrastat)
n=124 participants at risk
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
Long Tirofiban: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
|
|---|---|---|---|
|
General disorders
Catheter Site Haematoma
|
3.3%
7/209 • Number of events 7 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
4.0%
8/202 • Number of events 8 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
3.2%
4/124 • Number of events 4 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
General disorders
Application Site Haemorrhage
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
2.5%
5/202 • Number of events 5 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
1.6%
2/124 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
General disorders
Infusion Site Haematoma
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
General disorders
Pain
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
General disorders
Pyrexia
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
General disorders
Vessel Puncture Site Haemorrhage
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Investigations
Troponin Increased
|
3.8%
8/209 • Number of events 8 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
3.0%
6/202 • Number of events 6 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
3.2%
4/124 • Number of events 4 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Investigations
Troponin T Increased
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Investigations
Blood Glucose Decreased
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Investigations
Occult Blood Positive
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Investigations
Troponin I Increased
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Angina Pectoris
|
1.9%
4/209 • Number of events 4 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.99%
2/202 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.96%
2/209 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Myocardial Infarction
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Post Procedural Myocardial Infarction
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
1.5%
3/202 • Number of events 3 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
1.6%
2/124 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
1.4%
3/209 • Number of events 3 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Incision Site Haemorrhage
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.99%
2/202 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Graft Haemorrhage
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Mental Status Change Postoperative
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Haematoma
|
0.96%
2/209 • Number of events 2 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
2.0%
4/202 • Number of events 4 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Hypotension
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
2.4%
3/124 • Number of events 3 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Haemorrhage
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Vascular Dissection
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Embolism
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Vascular disorders
Vessel Perforation
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Gastrointestinal Angiodysplasia
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Epitaxis
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral Pain Syndrome
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Renal and urinary disorders
Haematuria
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Renal and urinary disorders
Nephropathy
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Eye disorders
Eye Pain
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Eye disorders
Ocular Hyperaemia
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Eye disorders
Dizziness
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Nervous system disorders
Neurological Decompensation
|
0.48%
1/209 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Immune system disorders
Contrast Media Allergy
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Product Issues
Thrombosis in Device
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.50%
1/202 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/124 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Reproductive system and breast disorders
Testicular Haemorrhage
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/209 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.00%
0/202 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
0.81%
1/124 • Number of events 1 • 48 hours or hospital discharge, whichever came first
The Investigator periodically assessed patients for the occurrence of adverse events. To avoid bias in eliciting adverse events, patients were asked the following non-leading question: "How are you feeling?" All adverse events (serious and non-serious) reported by the patient will be followed until the event has resolved or has stabilized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place